70 Governance Advisor jobs in Bahrain

Principal AI Ethics and Governance Advisor

00123 Hamala, Northern BHD150000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

contractor
Our client is at the forefront of artificial intelligence innovation and is seeking an exceptional Principal AI Ethics and Governance Advisor to guide the responsible development and deployment of cutting-edge AI technologies. This senior-level position will be instrumental in establishing robust ethical frameworks, governance policies, and risk management strategies to ensure AI systems are fair, transparent, accountable, and aligned with societal values. The ideal candidate will possess a profound understanding of AI, machine learning, ethics, law, and public policy, coupled with extensive experience in advising senior leadership on complex ethical dilemmas.

Responsibilities:
  • Develop, implement, and oversee the company's AI ethics and governance framework, policies, and procedures.
  • Conduct thorough ethical risk assessments for new and existing AI projects, identifying potential biases, fairness issues, and privacy concerns.
  • Advise product development, engineering, and research teams on ethical considerations throughout the AI lifecycle, from ideation to deployment and monitoring.
  • Collaborate with legal, compliance, and public policy teams to ensure AI systems comply with relevant regulations and industry standards.
  • Engage with external stakeholders, including academics, regulators, and civil society organizations, to foster dialogue and advance responsible AI practices.
  • Develop and deliver training programs on AI ethics and responsible AI for employees across the organization.
  • Lead the establishment of mechanisms for accountability and redress related to AI system impacts.
  • Stay current with the rapidly evolving landscape of AI ethics, regulations, and best practices globally.
  • Contribute to thought leadership in the AI ethics domain through publications, presentations, and participation in industry forums.
  • Champion a culture of ethical awareness and responsible innovation within the organization.
Qualifications:
  • Advanced degree (Master's or Ph.D.) in a relevant field such as Computer Science, AI, Philosophy, Law, Public Policy, Ethics, or a related interdisciplinary area.
  • Minimum of 8 years of progressive experience in AI ethics, responsible AI, technology governance, or a related field.
  • Deep technical understanding of AI and machine learning concepts, methodologies, and applications.
  • Proven expertise in developing and implementing ethical frameworks and governance structures for complex technological systems.
  • Strong knowledge of relevant legal and regulatory frameworks governing AI and data privacy (e.g., GDPR, AI Act).
  • Exceptional analytical, critical thinking, and problem-solving skills.
  • Excellent written and verbal communication skills, with the ability to articulate complex concepts clearly to diverse audiences.
  • Demonstrated ability to influence and advise senior stakeholders on sensitive ethical and strategic issues.
  • Experience in developing and conducting ethical impact assessments.
  • Familiarity with AI bias detection and mitigation techniques.
Join our pioneering team in Sanad, Capital, BH , and play a critical role in shaping the future of artificial intelligence responsibly. This position offers a unique opportunity to work on groundbreaking AI initiatives and contribute to a more ethical technological landscape.
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Specialist

5121 Northern, Northern BHD70000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is seeking a meticulous and experienced Regulatory Affairs Specialist to join their team in the pharmaceutical sector. This vital role involves ensuring that all company products comply with relevant national and international regulations governing the pharmaceutical industry. You will be responsible for preparing, submitting, and managing regulatory documentation, liaising with health authorities, and staying informed about evolving regulatory landscapes. The ideal candidate will have a strong understanding of drug development processes and a proven ability to navigate complex regulatory requirements.

Responsibilities:
  • Prepare and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals to health authorities.
  • Ensure all regulatory documentation is accurate, complete, and compliant with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
  • Maintain a deep understanding of global pharmaceutical regulations and guidelines.
  • Liaise with regulatory agencies (e.g., FDA, EMA, SFDA) on behalf of the company.
  • Review and approve promotional materials, labeling, and advertising for regulatory compliance.
  • Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
  • Monitor changes in regulations and assess their impact on company products and processes.
  • Manage post-market surveillance activities and pharmacovigilance reporting.
  • Conduct internal audits to ensure compliance with regulatory standards.
  • Develop and implement regulatory strategies for product development and lifecycle management.
  • Review and approve batch records and quality control data for regulatory submissions.
  • Participate in regulatory inspections and respond to queries from health authorities.
  • Collaborate with external partners and contract research organizations (CROs) on regulatory matters.
  • Maintain regulatory databases and filing systems.
  • Contribute to the development of company policies and procedures related to regulatory affairs.
  • Assess the regulatory status of products in different markets.
  • Support the preparation of responses to deficiency letters from regulatory agencies.
  • Ensure compliance with serialization and track-and-trace requirements.
  • Provide training to staff on regulatory compliance topics.
  • Build and maintain strong relationships with key regulatory stakeholders.
Qualifications:
  • Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Master's degree is a plus.
  • Minimum of 4-6 years of experience in regulatory affairs within the pharmaceutical industry.
  • Proven experience in preparing and submitting regulatory dossiers for different types of applications.
  • In-depth knowledge of global pharmaceutical regulations, ICH guidelines, and regional requirements.
  • Excellent written and verbal communication skills, with strong attention to detail.
  • Proficiency in regulatory information management (RIM) systems.
  • Strong analytical and problem-solving abilities.
  • Ability to work independently and collaboratively in a team environment.
  • Proficiency in English and strong technical writing skills.
  • Familiarity with drug development lifecycle and manufacturing processes.
  • Experience with regulatory submissions in the Middle East region is advantageous.
  • Ability to manage multiple projects and prioritize tasks effectively.
  • High ethical standards and commitment to compliance.
  • Adaptability to evolving regulatory frameworks.
  • Experience interacting with regulatory agencies.
This role is based in our modern facility and offers a fantastic opportunity to contribute to vital healthcare solutions.
Location: Shakhura, Northern, BH
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Specialist

06250 Seef, Capital BHD70000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a prominent firm in the biotechnology sector, is seeking a diligent and experienced Regulatory Affairs Specialist to join their esteemed legal and compliance team in **Jidhafs, Capital, BH**. This vital role ensures that the company's products and operations adhere to all relevant national and international regulatory standards. The ideal candidate will possess a thorough understanding of regulatory frameworks, submission processes, and compliance requirements within the biotechnology industry. Key responsibilities include preparing, reviewing, and submitting regulatory documentation to health authorities for product approvals and ongoing compliance. You will monitor changes in regulatory legislation and guidelines, assessing their impact on the company's products and strategies. The successful applicant will liaise with regulatory agencies, manage post-market surveillance activities, and ensure that product labeling and marketing materials are compliant. You will also provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing. A Bachelor's degree in a life science, chemistry, pharmacy, or a related field is required, along with at least 4 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry. Knowledge of GMP, GCP, and GLP principles is essential. Excellent analytical, written, and verbal communication skills are crucial for successful interactions with regulatory bodies and internal stakeholders. Experience with dossier preparation and submission software is a significant advantage. This is an excellent opportunity to contribute to the compliance and market access of innovative biotechnology products in **Jidhafs, Capital, BH**.
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist

20744 Hamad Town, Northern BHD100000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is seeking a highly qualified Senior Regulatory Affairs Specialist to join their team. This role offers a hybrid work arrangement, blending remote work with necessary on-site responsibilities for critical meetings and operational tasks. You will be responsible for ensuring compliance with all relevant regulations and guidelines governing our client's products and operations. This includes preparing and submitting regulatory filings, responding to inquiries from regulatory agencies, and staying abreast of changes in the regulatory landscape. The Senior Regulatory Affairs Specialist will provide strategic guidance on regulatory matters, conduct regulatory assessments for new products and processes, and develop regulatory strategies to support business objectives. A deep understanding of the specific regulatory frameworks relevant to the industry is essential. You will collaborate closely with R&D, marketing, and legal departments to ensure alignment on regulatory requirements. The ideal candidate will have a Bachelor's or Master's degree in a scientific, technical, or legal field, with significant experience in regulatory affairs. Excellent analytical, written, and verbal communication skills are paramount, as is the ability to interpret complex regulations and apply them to practical business scenarios. This role requires meticulous attention to detail, strong project management skills, and the ability to work both independently and collaboratively in a hybrid setting. Your expertise will be crucial in navigating the regulatory environment and ensuring market access for our client's offerings.

Responsibilities:
  • Ensure compliance with all applicable regulations.
  • Prepare and submit regulatory filings and applications.
  • Respond to inquiries from regulatory authorities.
  • Develop and implement regulatory strategies.
  • Conduct regulatory assessments for new products and processes.
  • Monitor and interpret regulatory changes.
  • Collaborate with internal departments on regulatory matters.
  • Maintain regulatory documentation and databases.
  • Provide regulatory training to staff.
Qualifications:
  • Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
  • 5+ years of experience in regulatory affairs.
  • In-depth knowledge of relevant regulatory frameworks.
  • Experience with regulatory submissions and filings.
  • Strong analytical and problem-solving skills.
  • Excellent written and verbal communication abilities.
  • Proficiency in regulatory information management systems.
  • Ability to interpret and apply complex regulations.
  • Strong project management and organizational skills.
This advertiser has chosen not to accept applicants from your region.

Lead Regulatory Affairs Specialist

98765 Bilad Al Qadeem, Capital BHD90000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is a distinguished global leader in the (Specify Industry, e.g., Pharmaceutical or Medical Device) sector, seeking a seasoned Lead Regulatory Affairs Specialist to bolster their compliance and product approval endeavors. This is a critical fully remote role, enabling you to contribute significantly to our operations from your chosen location. You will be tasked with overseeing and managing all aspects of regulatory affairs, ensuring that our products meet the stringent requirements of various international regulatory bodies and agencies. Your responsibilities will encompass preparing and submitting regulatory dossiers, managing post-market surveillance, and staying abreast of evolving regulatory landscapes and guidelines. You will collaborate closely with R&D, Quality Assurance, and Marketing departments to ensure regulatory compliance throughout the product lifecycle. Key activities include developing regulatory strategies, conducting regulatory impact assessments, and providing guidance on compliance matters. The ideal candidate will possess a Bachelor’s degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) or a related discipline, coupled with a minimum of 8 years of hands-on experience in regulatory affairs, with a strong emphasis on regulatory submissions and strategy. Proven expertise in navigating regulatory pathways for (Specific product type) is highly desirable. Exceptional attention to detail, strong analytical and problem-solving skills, and outstanding written and verbal communication abilities are essential. This is a remote-first position, demanding a high degree of self-discipline, organization, and the ability to work autonomously while maintaining seamless collaboration with global teams through digital platforms. You will play a pivotal role in ensuring market access for our innovative products and maintaining our company's reputation for quality and compliance. A Master's degree or specialized regulatory affairs certification would be an advantage. Our client is committed to fostering a culture of excellence and provides an environment where regulatory professionals can truly make a difference.
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist

33334 Askar, Southern BHD100000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our pharmaceutical client is seeking a highly motivated Senior Regulatory Affairs Specialist to join their dedicated team. This fully remote position will play a critical role in ensuring compliance with global regulatory requirements for drug development and marketing. You will be responsible for preparing and submitting regulatory documentation, interacting with health authorities, and providing strategic regulatory guidance throughout the product lifecycle. Your expertise in regulatory submissions and knowledge of pharmaceutical regulations are essential.
Key Responsibilities:
  • Prepare, review, and submit regulatory filings (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
  • Develop and implement regulatory strategies for product development and lifecycle management.
  • Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
  • Serve as a primary point of contact for regulatory agencies.
  • Interpret and advise on regulatory guidelines and policies.
  • Review and approve promotional materials and labeling for regulatory compliance.
  • Conduct regulatory due diligence for potential partnerships and acquisitions.
  • Maintain regulatory databases and documentation systems.
  • Collaborate with cross-functional teams, including R&D, clinical affairs, quality assurance, and commercial.
  • Stay updated on emerging regulatory trends and guidelines.

Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Master's degree or Pharm.D. preferred.
  • Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
  • In-depth knowledge of global regulatory submission processes and requirements (FDA, EMA, etc.).
  • Experience with preparing and submitting electronic regulatory dossiers (eCTD).
  • Strong understanding of drug development processes and lifecycle management.
  • Excellent analytical, problem-solving, and critical thinking skills.
  • Exceptional written and verbal communication skills, with strong attention to detail.
  • Ability to work independently and manage multiple projects in a remote environment.

This is an exciting opportunity for a seasoned regulatory professional to contribute to bringing life-saving medications to market, all within a flexible, fully remote work setting.
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist

1011 Tubli, Central BHD135000 Annually WhatJobs

Posted 11 days ago

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a prominent international law firm with a strong practice in the Middle East, is seeking an experienced Senior Regulatory Affairs Specialist to join their esteemed legal team in **Janabiyah, Northern, BH**. This crucial role requires a deep understanding of the regulatory landscape in Bahrain and the wider GCC region, focusing on compliance and legal advisory services for diverse industries. The Senior Regulatory Affairs Specialist will be responsible for advising clients on navigating complex regulatory frameworks, obtaining necessary licenses and permits, and ensuring ongoing compliance with local laws and international standards. You will conduct thorough regulatory research, analyze legislative changes, and provide strategic guidance to clients to mitigate legal and operational risks. This position demands exceptional analytical skills, meticulous attention to detail, and strong communication abilities to effectively liaise with government agencies, regulatory bodies, and clients. The ideal candidate will possess a comprehensive knowledge of corporate law, commercial regulations, and industry-specific compliance requirements.

Key Responsibilities:
  • Provide expert advice on regulatory compliance and legal requirements in Bahrain and the GCC.
  • Assist clients in obtaining licenses, permits, and approvals from relevant authorities.
  • Monitor regulatory changes and assess their impact on client businesses.
  • Develop and implement compliance programs and policies for clients.
  • Conduct regulatory due diligence and risk assessments.
  • Prepare and review regulatory submissions and documentation.
  • Liaise effectively with government agencies and regulatory bodies.
  • Advise on corporate governance and corporate secretarial matters.
  • Support legal teams in complex transactions and cross-border dealings.
  • Ensure clients adhere to industry-specific regulations and best practices.

Qualifications:
  • Law degree (LLB or JD) or a relevant degree in Public Administration, Business, or Economics.
  • Minimum of 7 years of experience in regulatory affairs, compliance, legal advisory, or corporate governance.
  • In-depth knowledge of Bahraini and GCC regulatory environments and business laws.
  • Experience in liaising with government authorities and regulatory bodies.
  • Strong analytical, research, and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Ability to manage multiple projects and meet demanding deadlines.
  • Proficiency in legal research databases and compliance software.
  • Understanding of corporate law and company formation procedures.
  • Fluency in English is essential; Arabic language proficiency is highly advantageous.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Governance advisor Jobs in Bahrain !

Regulatory Affairs Executive & Warehouse Pharmacist

Manama, Capital Zahrawi Group

Posted 10 days ago

Job Viewed

Tap Again To Close

Job Description

Regulatory Affairs Executive & Warehouse Pharmacist - (484) About Zahrawi Group

Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.

Job Brief

The incumbent is responsible for all Product Classification/Manufacturing Site Registration and Product Registration and to ensure that all documents required are available and are submitted on time.

ACCOUNTABILITIES

Adhere to all Zahrawi Policies & Procedures as applicable.

Regulatory Affairs:

Ensure that Zahrawi’s products comply with the regulations of the NHRA.

Keep up to date with the latest changes in regulatory legislation and guidelines.

Liaise and negotiate with regulatory authority to ensure a smooth registration process.

Provide advice about regulations to customers/suppliers.

Analyze product complaints and make recommendations to solve the problem and to avoid them in the future.

  • Prepare and apply for the permit document as per the NHRA guidelines and verify the items being imported and the documents required.
  • Apply for the NHRA regulated products permits on the NHRA website as per the specified guidelines.
  • Register and submit the permits for SCE when required.
  • Resubmit any permits that have not been approved and make sure all the information provided is correct and attach any new documents if required.
  • Prepare daily report regarding the rejections/ delays for NHRA importation permits and reasons related to that.
  • Communicate with the existing and new suppliers regarding NHRA importation rules and policies.
  • Upload on the NHRA importation system any new classifications or registration certificates.
  • Ensure that all urgent requests from the Sales team and suppliers are dealt with in a fast manner and ensure that all documents are in place.
  • Report any deviation from NHRA guidelines of imported shipments and take the corrective and preventive action accordingly.
  • Review on a regular basis the NHRA importation process of distribution agreements.
  • Ensure that the NHRA license is renewed before expiry date to avoid importation disturbance.
  • Segregate the imported products as per HS code in coordination with logistic team and confirm if products are NHRA regulated or not.
  • Coordinate with the Procurement & Logistics Team to update all the required documents in time to avoid importation rejections.
  • Act as the LRPPV (Local Responsible Person for Pharmacovigilance).
  • Perform regulatory intelligence by screening the NHRA websites on a weekly basis.
  • Screen all scientific and medical literature to stay up to date with the latest regulations.
  • Comply with local regulatory requirements for reporting adverse drug reactions and submission of safety reports.
  • Responsible for all Pharmacovigilance related work and assigned as the LRPPV (Local Responsible Person for Pharmacovigilance).
  • Report Adverse Drug Reactions (ADRs) for all products by collating the needed information and incorporating customer’s comments.
  • Fill the Council for International Organizations of Medical Sciences (CIOMS) forms with all the information collected from the ADRs.
  • Send all CIOMS forms to the Manufacturers and the relevant authorities.
  • Manage the Pharmacovigilance process of Zahrawi by preparing all SOPs, product safety reviews and literature reviews when needed.
  • Maintain a high level of standard to ensure that all work is moving smoothly and that there are no delays.
  • Prepare and review all SOP’s Pharmacovigilance plans for all Zahrawi Suppliers.
  • Prepare all Registration and Pharmacovigilance forms and communicate the same to the Suppliers and stakeholders.
  • Provide trainings to all internal divisions on the current Pharmacovigilance Policies & Procedures.

Individual Case Study Reports (ICSRs):

  • Report any spontaneous Individual Case Study Reports (ICSRs) to the Supplier and the Health Authority.
  • Maintain a soft and hard copy of all ICSRs for the future.
  • Track and follow up with all active ICSR reconciliation with the respective authorities.
  • Report all Suspected and Unexpected Serious Adverse Reactions to relevant Health Authorities.

Product Classification & Registration:

Ensure that all required documents and actions for Product Classification/Manufacturing Site Registration and Product Registration are available.

Prepare all required documents to be submitted for Product Classification under NHRA.

Prepare all required documents to be submitted for Manufacturing Site registration under NHRA.

Prepare all the Dossiers to be submitted to NHRA for product registration.

Collect all necessary documents from Supplier to submit for Health Authorities.

Quality Assurance:

  • Monitor all Cold Products from point of receiving until delivery of products to customers along with Data Logger results within the set temperature limits.
  • Examine the packing of goods from the cold storage and monitor the Data Logger Report to ensure consistency.
  • Check the quality of the vehicles, warehouse cleanliness, temperature control mechanism, storage conditions and validity of goods on shelves on a regular basis.
  • Ensure all Zahrawi Cold Vans/Delivery Vehicles, Data Loggers are calibrated regularly and update the temperature mapping of the Warehouse.
  • Ensure all required licenses and registrations as well as calibration renewals are updated before their expiry dates.
  • Review all technical and quality agreements with suppliers and customers on a regular basis.

Warehouse Quality Check:

Ensure that the Warehouse & Service Room are kept clean and organized.

Ensure that the temperature control mechanism and hygiene standards are maintained in the Warehouse.

Ensure a quick and accurate release of shipments from NHRA to avoid any delays in transporting the products to the customer.

Ensure that all stock areas are segregated properly into: Dispatching, Receiving, Returns, Hold and Expired and that no mix-up could happen at any time.

Product Quality Check:

Ensure that a sample of each batch of products is secured from the WH Assistants and provide the samples along with a progress report and supplier invoice to the Warehouse Operation, QA & RA Manager for NHRA release approval.

Check all shipments leaving the Warehouse are sealed and packed properly and if the vehicle is fit for transporting the products.

Compile all Quality Inspection Forms prepared by the Sr. Driver & Fleet Coordinator and prepare a monthly report.

Generate a discrepancy report to the Warehouse Operation, QA & RA Manager for MOH release approval for any late findings (excess, damaged or expired goods) in the shipment.

Audit:

  • Prepare any documentation needed for internal and external audits.
  • File all documents in the corresponding files to ensure all are available and are correct.
  • Evaluate the suggestions after the audit and implement them when possible.

Admin:

  • Develop a professional relationship with the NHRA staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
  • Represent Zahrawi in NHRA and different authorities.
  • Negotiate with regulatory authorities for marketing authorization.
  • Attend and respond to calls and emails from customers, the Sales team and other support staff.
  • Assist the Warehouse Coordinators with relevant documents when requested.
  • Coordinate with the Procurement team and assist them with any question they or the Suppliers may have related to NHRA importation.
  • Keep track of all registration application on Zahrawi’s tracking system.
  • Record all active Zahrawi licenses on the Shared folder and ensure they are updated.
REQUIREMENTS
  • Education: Bachelors Degree in Pharmacy
  • Candidates must be based in Bahrain.
  • Bahraini national is preferred.
  • Candidates must have a valid Pharmacist license.
  • RAO license is a plus.
  • Experience: Fresh graduates or 1+ years of relevant experience in regulatory affairs within Bahrain is preferred.
  • Job Specific Skills: Excellent Interpersonal Skills & Good English – Good computer skills in Ms. Office (Excel– ERP/Oracle system) - Knowledge about Regulatory Affairs, Product Classification and Importation Regulations as per NHRA.
#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Senior Pharmaceutical Regulatory Affairs Specialist

21503 Busaiteen, Muharraq BHD72000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our client is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their team in **Busaiteen, Muharraq, BH**. This vital role is responsible for ensuring compliance with all relevant pharmaceutical regulations and guidelines for product registration and lifecycle management. The ideal candidate will possess in-depth knowledge of regulatory submission processes, a strong understanding of global pharmaceutical markets, and meticulous attention to detail. You will manage regulatory submissions, liaise with health authorities, and advise internal teams on regulatory requirements.

Key responsibilities include:
  • Preparing, submitting, and managing regulatory dossiers for new drug applications (NDAs) and variations.
  • Ensuring all regulatory submissions comply with local and international requirements (e.g., FDA, EMA, SFDA).
  • Liaising with health authorities and responding to queries during the review process.
  • Monitoring regulatory changes and providing updates and guidance to internal stakeholders.
  • Developing and implementing regulatory strategies for product lifecycle management.
  • Reviewing labeling, promotional materials, and marketing claims for regulatory compliance.
  • Participating in regulatory inspections and audits.
  • Collaborating with R&D, Quality Assurance, and Commercial teams to ensure regulatory alignment.
  • Maintaining regulatory databases and records.
  • Providing training on regulatory compliance to relevant personnel.

The ideal candidate will hold a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or equivalent advanced degree is a plus. A minimum of 5 years of experience in pharmaceutical regulatory affairs is required. Strong knowledge of ICH guidelines and experience with eCTD submissions are essential. Familiarity with different global regulatory agencies is highly desirable. Excellent written and verbal communication skills, as well as strong analytical and problem-solving abilities, are necessary. This is an on-site position at our **Busaiteen, Muharraq, BH** facility.
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist - Pharmaceutical

100 Manama, Capital BHD85000 Annually WhatJobs

Posted today

Job Viewed

Tap Again To Close

Job Description

full-time
Our client, a leading pharmaceutical company renowned for its commitment to innovation and patient well-being, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their dedicated team in Manama, Capital, BH . This critical role involves ensuring compliance with all relevant national and international pharmaceutical regulations, facilitating the successful registration and lifecycle management of medicinal products. The ideal candidate will possess a profound understanding of the pharmaceutical industry's regulatory landscape and a proven ability to navigate complex submission processes.

As a Senior Regulatory Affairs Specialist, you will be responsible for preparing, reviewing, and submitting regulatory dossiers for new drug applications, variations, and renewals. You will liaise with health authorities, manage regulatory timelines, and provide expert guidance on regulatory strategies to internal stakeholders, including R&D, marketing, and manufacturing departments. Key responsibilities include staying abreast of evolving regulatory requirements, conducting regulatory intelligence assessments, and ensuring that all product labeling and promotional materials comply with applicable laws and guidelines. This position requires meticulous attention to detail, strong project management skills, and the ability to manage multiple priorities effectively. A collaborative spirit and excellent communication skills are essential for success in this role, as you will be working with cross-functional teams and external partners.

Key Responsibilities:
  • Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations, renewals) to health authorities.
  • Develop and implement regulatory strategies to support product development and commercialization.
  • Act as the primary point of contact for regulatory agencies.
  • Interpret and communicate regulatory guidelines and requirements to internal teams.
  • Ensure compliance of product labeling, packaging, and promotional materials with regulatory standards.
  • Conduct regulatory intelligence gathering and analysis to identify potential impacts on the business.
  • Manage the lifecycle of approved products, including post-approval changes and reporting.
  • Provide regulatory input and support for clinical trial applications.
  • Contribute to the development and maintenance of regulatory quality systems.
Qualifications:
  • Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
  • Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry.
  • In-depth knowledge of pharmaceutical regulatory requirements and guidelines (e.g., ICH, FDA, EMA, SFDA).
  • Proven experience in preparing and submitting marketing authorization applications.
  • Excellent written and verbal communication skills, with strong attention to detail.
  • Strong project management and organizational skills.
  • Ability to work independently and collaboratively in a team environment.
  • Proficiency in regulatory information management systems is a plus.
This is an outstanding opportunity to contribute to a forward-thinking pharmaceutical organization and shape the regulatory pathway of essential medicines in Manama, Capital, BH .
This advertiser has chosen not to accept applicants from your region.
 

Nearby Locations

Other Jobs Near Me

Industry

  1. request_quote Accounting
  2. work Administrative
  3. eco Agriculture Forestry
  4. smart_toy AI & Emerging Technologies
  5. school Apprenticeships & Trainee
  6. apartment Architecture
  7. palette Arts & Entertainment
  8. directions_car Automotive
  9. flight_takeoff Aviation
  10. account_balance Banking & Finance
  11. local_florist Beauty & Wellness
  12. restaurant Catering
  13. volunteer_activism Charity & Voluntary
  14. science Chemical Engineering
  15. child_friendly Childcare
  16. foundation Civil Engineering
  17. clean_hands Cleaning & Sanitation
  18. diversity_3 Community & Social Care
  19. construction Construction
  20. brush Creative & Digital
  21. currency_bitcoin Crypto & Blockchain
  22. support_agent Customer Service & Helpdesk
  23. medical_services Dental
  24. medical_services Driving & Transport
  25. medical_services E Commerce & Social Media
  26. school Education & Teaching
  27. electrical_services Electrical Engineering
  28. bolt Energy
  29. local_mall Fmcg
  30. gavel Government & Non Profit
  31. emoji_events Graduate
  32. health_and_safety Healthcare
  33. beach_access Hospitality & Tourism
  34. groups Human Resources
  35. precision_manufacturing Industrial Engineering
  36. security Information Security
  37. handyman Installation & Maintenance
  38. policy Insurance
  39. code IT & Software
  40. gavel Legal
  41. sports_soccer Leisure & Sports
  42. inventory_2 Logistics & Warehousing
  43. supervisor_account Management
  44. supervisor_account Management Consultancy
  45. supervisor_account Manufacturing & Production
  46. campaign Marketing
  47. build Mechanical Engineering
  48. perm_media Media & PR
  49. local_hospital Medical
  50. local_hospital Military & Public Safety
  51. local_hospital Mining
  52. medical_services Nursing
  53. local_gas_station Oil & Gas
  54. biotech Pharmaceutical
  55. checklist_rtl Project Management
  56. shopping_bag Purchasing
  57. home_work Real Estate
  58. person_search Recruitment Consultancy
  59. store Retail
  60. point_of_sale Sales
  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
View All Governance Advisor Jobs