615 Pharmaceutical Services jobs in Bahrain
Regulatory Affairs Executive
BHD30000 - BHD60000 Y
Zahrawi Medical
Posted today
Job Viewed
Job Description
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 BriefThe 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
Policies & Procedures:
- 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.
Importation Permits:
- 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.
Importation Rules & Regulations:
- 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 request 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.
Pharmacovigilance:
- 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 and prepare 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 communicating 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
- Additional details:
- Candidates must be based in Bahrain and should be willing to move to company visa (when applicable)
- Candidates must have a valid Pharmacist license
- Experience: 3 + years of relevant experience in regulatory affairs within Bahrain.
- 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
Location: Bahrain - Manama
Job Type: FULLTIME
Job Posting Date:
Division/Department: Warehouse Operation and Distribution
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Specialist
3001 Northern, Northern
BHD5000 Monthly
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client, a growing pharmaceutical company, is seeking a diligent and knowledgeable Regulatory Affairs Specialist to join their team. This role will be based in **Shakhura, Northern, BH**, with a hybrid work arrangement offering a blend of in-office and remote flexibility.
The Regulatory Affairs Specialist will play a vital role in ensuring that the company's products comply with all relevant national and international regulations. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This position requires meticulous attention to detail, strong analytical skills, and a thorough understanding of pharmaceutical regulatory processes.
Key Responsibilities:
Qualifications:
The Regulatory Affairs Specialist will play a vital role in ensuring that the company's products comply with all relevant national and international regulations. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This position requires meticulous attention to detail, strong analytical skills, and a thorough understanding of pharmaceutical regulatory processes.
Key Responsibilities:
- Prepare, compile, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to health authorities in target markets.
- Maintain up-to-date knowledge of global regulatory requirements and guidelines applicable to pharmaceutical products.
- Respond to queries from regulatory agencies during the review process.
- Ensure that all product labeling and promotional materials are compliant with regulatory standards.
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Liaise with internal departments (e.g., R&D, Quality, Manufacturing, Marketing) to gather necessary information for regulatory submissions.
- Conduct regulatory intelligence activities to monitor changes in the regulatory environment.
- Evaluate the regulatory impact of product changes and new development projects.
- Participate in regulatory strategy development for new product registrations.
- Maintain regulatory databases and filing systems.
- Support audits and inspections by health authorities.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline; advanced degree preferred.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Thorough understanding of regulatory submission requirements and processes in key markets (e.g., GCC, FDA, EMA).
- Experience with Common Technical Document (CTD) format.
- Strong analytical and problem-solving skills with exceptional attention to detail.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory issues clearly.
- Proficiency in regulatory information management systems is a plus.
- Ability to work effectively both independently and as part of a cross-functional team.
- Strong organizational and project management skills.
- Adaptability to changing regulatory requirements and business priorities.
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Affairs Specialist
67890 Saar, Northern
BHD90000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and knowledgeable Regulatory Affairs Specialist to ensure compliance with all relevant industry regulations and standards. This role is vital for navigating the complex regulatory landscape and facilitating the smooth market entry and lifecycle management of our client's products. The ideal candidate will have a thorough understanding of regulatory requirements, submission processes, and quality management systems. You will be responsible for preparing, reviewing, and submitting regulatory documentation to health authorities and other regulatory bodies. This includes developing regulatory strategies, advising on compliance requirements, and managing regulatory submissions throughout their lifecycle.
Key responsibilities include monitoring changes in regulations and guidelines, assessing their impact on the company's products and operations, and implementing necessary changes. You will work closely with R&D, quality assurance, and marketing teams to ensure that all activities and products are compliant. The role demands strong analytical skills, excellent written and verbal communication, and the ability to interpret and apply complex regulatory texts. Experience with regulatory databases and documentation management systems is essential. Maintaining strong relationships with regulatory agencies is also a key aspect of this position. The successful candidate will have a Bachelor's degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) or a related discipline, with at least 5 years of experience in regulatory affairs, preferably within a regulated industry. Knowledge of international regulatory requirements is highly advantageous. This role offers a hybrid work arrangement, combining office-based collaboration with remote flexibility, based in **Saar, Northern, BH**. Join our client and play a critical role in their regulatory success.
Key responsibilities include monitoring changes in regulations and guidelines, assessing their impact on the company's products and operations, and implementing necessary changes. You will work closely with R&D, quality assurance, and marketing teams to ensure that all activities and products are compliant. The role demands strong analytical skills, excellent written and verbal communication, and the ability to interpret and apply complex regulatory texts. Experience with regulatory databases and documentation management systems is essential. Maintaining strong relationships with regulatory agencies is also a key aspect of this position. The successful candidate will have a Bachelor's degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) or a related discipline, with at least 5 years of experience in regulatory affairs, preferably within a regulated industry. Knowledge of international regulatory requirements is highly advantageous. This role offers a hybrid work arrangement, combining office-based collaboration with remote flexibility, based in **Saar, Northern, BH**. Join our client and play a critical role in their regulatory success.
This advertiser has chosen not to accept applicants from your region.
2
Senior Regulatory Affairs Specialist
101 Bilad Al Qadeem, Capital
BHD90000 Annually
WhatJobs
Posted today
Job Viewed
Job Description
Our client, a distinguished law firm renowned for its expertise in corporate and commercial law, is seeking a highly knowledgeable and meticulous Senior Regulatory Affairs Specialist. This hybrid role will be based at our **Tubli, Capital, BH** offices and will focus on navigating the complex landscape of regulatory compliance for a diverse clientele. You will be responsible for monitoring regulatory changes, interpreting legislation, and developing strategies to ensure client adherence to all applicable laws and standards across various industries, including finance, healthcare, and technology. The ideal candidate will possess a deep understanding of Bahraini regulatory frameworks, excellent analytical skills, and the ability to translate complex regulations into actionable advice. You will work closely with legal teams, consultants, and clients to provide expert guidance, prepare regulatory submissions, and manage compliance initiatives. This position requires a proactive approach, meticulous attention to detail, and the ability to manage multiple client needs effectively.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Monitor, analyze, and interpret regulatory changes and legislation relevant to client industries.
- Develop and implement compliance strategies to ensure adherence to laws and regulations.
- Prepare and submit regulatory documentation and applications to relevant authorities.
- Conduct regulatory impact assessments and advise clients on potential risks and opportunities.
- Liaise with government agencies, regulatory bodies, and industry associations on behalf of clients.
- Assist in the development and implementation of internal compliance policies and procedures.
- Provide expert advice and training to clients on regulatory matters.
- Manage ongoing regulatory filings and reporting requirements.
- Conduct due diligence on regulatory aspects of potential transactions or business ventures.
- Stay abreast of emerging regulatory trends and best practices.
Qualifications:
- Bachelor's degree in Law, Public Administration, Economics, or a related field. Master's degree preferred.
- Minimum of 6 years of experience in regulatory affairs, compliance, or legal advisory roles, preferably within a law firm or corporate legal department.
- In-depth knowledge of regulatory frameworks in Bahrain across multiple sectors.
- Proven experience in regulatory analysis, strategy development, and submission management.
- Excellent analytical, research, and problem-solving skills.
- Strong understanding of legislative processes and government relations.
- Exceptional written and verbal communication skills, with the ability to articulate complex legal and regulatory information clearly.
- Meticulous attention to detail and organizational skills.
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Proficiency in relevant legal databases and compliance software.
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Specialist - Pharmaceutical
8765 Seef, Capital
BHD70000 Annually
WhatJobs
Posted 2 days ago
Job Viewed
Job Description
Our client, a distinguished pharmaceutical company, is looking for a meticulous and knowledgeable Regulatory Affairs Specialist to join their team in **Seef, Capital, BH**. This role is essential for ensuring that the company's products comply with all relevant national and international regulations throughout their lifecycle.
The successful candidate will be responsible for preparing, submitting, and maintaining regulatory filings for new drug applications, variations, and renewals. You will need to stay up-to-date with evolving regulatory landscapes, provide guidance on regulatory requirements to internal teams, and liaise with health authorities. A strong understanding of pharmaceutical development, manufacturing, and quality systems is crucial.
Key Responsibilities:
The successful candidate will be responsible for preparing, submitting, and maintaining regulatory filings for new drug applications, variations, and renewals. You will need to stay up-to-date with evolving regulatory landscapes, provide guidance on regulatory requirements to internal teams, and liaise with health authorities. A strong understanding of pharmaceutical development, manufacturing, and quality systems is crucial.
Key Responsibilities:
- Prepare and submit regulatory documentation to health authorities for product registration and lifecycle management.
- Ensure compliance with all applicable regulations, guidelines, and standards.
- Review and approve product labeling, promotional materials, and advertising.
- Liaise with regulatory agencies, responding to queries and facilitating approvals.
- Monitor changes in the regulatory environment and assess their impact on the company's products.
- Provide regulatory input and guidance to R&D, manufacturing, and marketing teams.
- Manage post-approval changes and ensure timely submission of variations.
- Develop and implement regulatory strategies for product development and commercialization.
- Maintain regulatory databases and filing systems.
- Participate in regulatory inspections and audits.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life sciences field. Master's degree is a plus.
- Minimum of 4 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of pharmaceutical regulations and guidelines (e.g., FDA, EMA, SFDA).
- Proven experience in preparing and submitting regulatory dossiers (e.g., CTD format).
- Strong understanding of drug development, manufacturing processes, and quality assurance.
- Excellent written and verbal communication skills.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to manage multiple projects and meet tight deadlines.
- Proficiency in regulatory information management systems.
- Experience interacting with health authorities.
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Manager - Pharmaceuticals
89012 Al Seef
BHD90000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
Our client, a rapidly expanding pharmaceutical company committed to developing innovative healthcare solutions, is seeking a highly skilled and experienced Regulatory Affairs Manager to join their esteemed team in Salmabad, Northern, BH . This pivotal role requires a strategic thinker with a comprehensive understanding of global pharmaceutical regulations and a proven ability to navigate complex submission processes. You will be responsible for developing and implementing regulatory strategies, ensuring compliance with all relevant health authority requirements, and managing the submission of new drug applications and variations. Key responsibilities include preparing and reviewing regulatory documentation, liaising with regulatory agencies, providing regulatory guidance to cross-functional teams, and staying abreast of evolving regulatory landscapes. The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field, along with at least 7 years of progressive experience in pharmaceutical regulatory affairs. Demonstrable experience with major regulatory bodies such as the FDA, EMA, and other international agencies is essential. Excellent written and verbal communication skills, strong analytical capabilities, and meticulous attention to detail are paramount. The ability to manage multiple projects simultaneously, prioritize effectively, and work collaboratively within a team environment is crucial. This role offers an exciting opportunity to contribute to the successful launch of groundbreaking pharmaceutical products and to influence regulatory policy. Our client values a proactive approach to problem-solving and a commitment to ethical practices. This hybrid role combines the benefits of in-office collaboration with the flexibility of remote work, offering a balanced work environment. We are looking for a leader who can champion regulatory excellence and drive compliance throughout the organization. If you are a dedicated professional passionate about shaping the future of medicine through strategic regulatory management, we encourage you to apply.
This advertiser has chosen not to accept applicants from your region.
5
Senior Regulatory Affairs Specialist
8372 Hamad Town, Northern
BHD95000 Annually
WhatJobs
Posted 4 days ago
Job Viewed
Job Description
Our client is actively seeking a highly motivated and detail-oriented Senior Regulatory Affairs Specialist to join their team in a fully remote capacity. This position is crucial for ensuring that all products meet stringent regulatory requirements across various global markets. You will be responsible for preparing, reviewing, and submitting regulatory filings, maintaining compliance documentation, and staying abreast of evolving regulatory landscapes. The ideal candidate will possess a deep understanding of regulatory strategies, submission processes, and compliance standards within the relevant industry. You will liaise with regulatory agencies, internal R&D, manufacturing, and quality teams to facilitate product approvals and ensure ongoing compliance. This role demands excellent analytical skills, meticulous record-keeping, and the ability to navigate complex regulatory frameworks independently.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and execute regulatory affairs strategies for product development and lifecycle management.
- Prepare and submit regulatory dossiers and applications to health authorities worldwide.
- Review product labeling, marketing materials, and technical documentation for regulatory compliance.
- Interpret and apply relevant regulations, guidelines, and standards.
- Liaise with regulatory agencies and serve as a primary contact for regulatory inquiries.
- Monitor changes in the regulatory environment and assess their impact on the company.
- Manage post-market surveillance activities and ensure ongoing product compliance.
- Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Marketing) to ensure regulatory requirements are met.
- Maintain regulatory databases and ensure accurate and up-to-date records.
- Provide regulatory training and guidance to internal stakeholders.
Qualifications:
- Bachelor's degree in a scientific, technical, or related field. Advanced degree (Master's, PhD) or equivalent experience preferred.
- Minimum of 6 years of experience in regulatory affairs within a relevant industry.
- Proven experience in preparing and submitting regulatory filings in key global markets.
- In-depth knowledge of relevant regulatory guidelines and requirements (e.g., FDA, EMA, ISO).
- Strong understanding of product development and manufacturing processes.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with a high degree of accuracy.
- Ability to manage multiple projects simultaneously and meet deadlines in a remote setting.
- High level of integrity, professionalism, and attention to detail.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Pharmaceutical services Jobs in Bahrain !
6
Senior Regulatory Affairs Specialist
228 Muharraq, Muharraq
BHD100000 Annually
WhatJobs
Posted 4 days ago
Job Viewed
Job Description
Our client, a groundbreaking biopharmaceutical company, is seeking a highly experienced and strategic Senior Regulatory Affairs Specialist to join their fully remote team. This crucial role will spearhead the development and execution of regulatory strategies for innovative new drug submissions and ongoing product lifecycle management. The ideal candidate will possess a deep understanding of global regulatory landscapes and a proven ability to navigate complex submission processes.
In this remote-first position, you will be responsible for preparing, compiling, and submitting regulatory documentation to health authorities worldwide, including but not limited to FDA, EMA, and other relevant agencies. You will conduct thorough regulatory intelligence gathering to stay ahead of evolving guidelines and ensure compliance. This includes analyzing new regulations, assessing their impact on company products and strategies, and recommending appropriate actions.
Key responsibilities include leading cross-functional teams in the development of regulatory submission plans, providing regulatory guidance on product development activities, and responding to queries from regulatory agencies. You will play a vital role in ensuring that all regulatory submissions are accurate, complete, and submitted in a timely manner. The ability to effectively communicate complex regulatory information to diverse audiences, both verbally and in writing, is essential. We are looking for a proactive individual who can independently manage multiple projects, drive regulatory success, and contribute significantly to bringing life-saving therapies to patients.
Qualifications:
In this remote-first position, you will be responsible for preparing, compiling, and submitting regulatory documentation to health authorities worldwide, including but not limited to FDA, EMA, and other relevant agencies. You will conduct thorough regulatory intelligence gathering to stay ahead of evolving guidelines and ensure compliance. This includes analyzing new regulations, assessing their impact on company products and strategies, and recommending appropriate actions.
Key responsibilities include leading cross-functional teams in the development of regulatory submission plans, providing regulatory guidance on product development activities, and responding to queries from regulatory agencies. You will play a vital role in ensuring that all regulatory submissions are accurate, complete, and submitted in a timely manner. The ability to effectively communicate complex regulatory information to diverse audiences, both verbally and in writing, is essential. We are looking for a proactive individual who can independently manage multiple projects, drive regulatory success, and contribute significantly to bringing life-saving therapies to patients.
Qualifications:
- Master's or Ph.D. degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 7 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Extensive experience in preparing and submitting Investigational New Drug (IND), New Drug Application (NDA), and Marketing Authorization Applications (MAA).
- In-depth knowledge of global regulatory guidelines (FDA, EMA, ICH).
- Proven ability to develop and implement successful regulatory strategies.
- Excellent written and verbal communication skills, with strong analytical and problem-solving abilities.
- Demonstrated experience working effectively in a remote, collaborative environment.
- Strong project management skills and the ability to manage multiple high-priority projects.
This advertiser has chosen not to accept applicants from your region.
7
Senior Regulatory Affairs Specialist
101 Bilad Al Qadeem, Capital
BHD85000 Annually
WhatJobs
Posted 5 days ago
Job Viewed
Job Description
Our client, a prominent player in the pharmaceutical industry, is seeking a seasoned Senior Regulatory Affairs Specialist to join their team. This is a fully remote position, allowing you the flexibility to work from your preferred location. You will be responsible for managing the preparation, submission, and maintenance of regulatory filings for pharmaceutical products in various global markets. This includes ensuring compliance with all relevant regulatory guidelines and requirements. Key responsibilities include developing regulatory strategies, authoring submission documents, liaising with regulatory agencies, and providing regulatory input throughout the product lifecycle. You will also stay abreast of evolving regulatory landscapes and advise internal teams on potential impacts. The ideal candidate will possess a Bachelor's or Master's degree in a life science, pharmacy, or a related field, combined with significant experience in regulatory affairs within the pharmaceutical or biotechnology sectors. A deep understanding of global regulatory submission requirements (e.g., FDA, EMA) is essential. Strong written and verbal communication skills are critical for preparing high-quality submission documents and effectively interacting with regulatory authorities and internal stakeholders. Excellent organizational skills, meticulous attention to detail, and the ability to manage multiple complex projects simultaneously are paramount. You must be proficient in regulatory information management systems and have a proven track record of successfully navigating complex regulatory pathways. This role offers the chance to significantly contribute to bringing life-saving therapies to patients worldwide, working within a collaborative and supportive remote environment. Our client is committed to fostering innovation and professional development for its employees.
This advertiser has chosen not to accept applicants from your region.
8
Senior Regulatory Affairs Specialist
703 Muharraq, Muharraq
BHD78000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client, a forward-thinking pharmaceutical company, is actively recruiting a Senior Regulatory Affairs Specialist to join our fully remote team. This crucial role will be responsible for ensuring our products comply with all applicable global regulatory requirements throughout their lifecycle. You will expertly navigate complex regulatory landscapes, prepare and submit regulatory filings, and maintain strong relationships with health authorities. This is an excellent opportunity for a seasoned regulatory professional to contribute significantly to our company's success from a remote location.
Responsibilities:
Responsibilities:
- Develop and implement regulatory strategies for product registration and lifecycle management.
- Prepare, review, and submit regulatory filings (e.g., NDAs, ANDAs, variations) to health authorities worldwide.
- Monitor and interpret evolving global regulatory requirements and guidelines.
- Liaise with regulatory agencies to facilitate product approvals and address inquiries.
- Collaborate with R&D, clinical, manufacturing, and marketing teams to ensure regulatory compliance.
- Provide regulatory guidance and support to cross-functional project teams.
- Maintain regulatory documentation and ensure compliance with relevant regulations and standards.
- Conduct regulatory assessments for new product development and post-market changes.
- Manage regulatory agency inspections and respond to audit findings.
- Contribute to the development and implementation of departmental SOPs and training programs.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline. A Master's degree or relevant professional certification is a plus.
- Minimum of 5-7 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Thorough understanding of global regulatory requirements for drug development and marketing authorization.
- Proven experience in preparing and submitting successful regulatory dossiers.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills, with the ability to effectively communicate with regulatory agencies and internal stakeholders.
- Ability to work independently, manage multiple projects, and meet tight deadlines in a remote work environment.
- Proficiency in regulatory information management systems (RIMS) and document management systems.
- Knowledge of quality assurance principles and GMP is beneficial.
- Detail-oriented with a commitment to accuracy and compliance.
This advertiser has chosen not to accept applicants from your region.
9