381 Certified Compliance Ethics Professional jobs in Bahrain
Regulatory Affairs Executive
BHD30000 - BHD60000 Y
Zahrawi Medical
Posted today
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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
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0
Regulatory Affairs Specialist
23456 Al Ghurayfah
BHD105000 Annually
WhatJobs
Posted 10 days ago
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Job Description
Our client is actively searching for a dedicated and detail-oriented Regulatory Affairs Specialist to join their fully remote pharmaceutical team. In this critical role, you will be responsible for ensuring that all products meet the stringent regulatory requirements of various international markets. Your expertise will be vital in navigating the complex landscape of pharmaceutical regulations, from initial product development through to marketing authorization and lifecycle management. Key responsibilities include preparing and submitting regulatory dossiers (e.g., IND, NDA, MAA), responding to queries from health authorities, and staying abreast of evolving regulatory guidelines and legislation worldwide. You will liaise with internal departments, including R&D, Quality Assurance, and Commercial, as well as external partners and regulatory agencies, all within a remote work environment. A strong understanding of global regulatory submission processes and experience with electronic submission platforms are essential. The ability to analyze complex scientific data and translate it into clear, concise regulatory documents is a must. You will play a key role in developing regulatory strategies to support product approval and commercialization. Excellent written and verbal communication skills are paramount, as is a meticulous approach to documentation and compliance. This position requires a proactive individual with strong analytical and problem-solving abilities who thrives in an independent, remote setting. A Bachelor's or Master's degree in a relevant scientific or technical field (e.g., pharmacy, chemistry, biology) and a minimum of 5 years of experience in pharmaceutical regulatory affairs are required. Experience with specific therapeutic areas or product types may be an advantage. This is an exceptional opportunity to contribute to global health initiatives by facilitating the timely access of innovative medicines to patients, all while enjoying the flexibility of a remote career.
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1
Pharmaceutical Regulatory Affairs Specialist
1015 Northern, Northern
BHD70000 Annually
WhatJobs
Posted today
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Job Description
Our client, a leading pharmaceutical company, is seeking a diligent and knowledgeable Pharmaceutical Regulatory Affairs Specialist to ensure compliance with all relevant regulations and guidelines. This critical role involves navigating the complex regulatory landscape for drug development, approval, and lifecycle management. The ideal candidate will possess a strong understanding of pharmaceutical regulations, excellent analytical skills, and meticulous attention to detail.
Key Responsibilities:
Key Responsibilities:
- Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities.
- Maintain a thorough understanding of current and evolving national and international pharmaceutical regulations.
- Liaise with regulatory agencies to facilitate the review and approval process for pharmaceutical products.
- Provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing.
- Monitor regulatory intelligence and assess the impact of new regulations on company products and strategies.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant quality standards.
- Manage post-approval regulatory activities, such as annual reports and safety updates.
- Review and approve promotional materials and labeling to ensure regulatory compliance.
- Participate in regulatory audits and inspections.
- Maintain accurate and organized regulatory databases and filing systems.
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science field. A Master's degree is advantageous.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of regulatory submission processes and requirements in key markets.
- Familiarity with ICH guidelines and regional regulatory frameworks.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills, with the ability to draft clear and concise regulatory documents.
- Meticulous attention to detail and a commitment to accuracy.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in regulatory information management systems is a plus.
- Must be able to work effectively within a hybrid model in **Shakhura, Northern, BH**.
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2
Senior Regulatory Affairs Specialist
98001 Galali
BHD105000 Annually
WhatJobs
Posted 3 days ago
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Job Description
Our client is a prominent international pharmaceutical company committed to developing and delivering life-changing medicines. We are seeking a highly knowledgeable and experienced Senior Regulatory Affairs Specialist to join our dedicated team at our **Sanad, Capital, BH** location. This role is crucial for ensuring that our products meet all necessary regulatory requirements for market approval and continued compliance in various global markets. You will be responsible for preparing, reviewing, and submitting regulatory dossiers to health authorities, including applications for new drug approvals, variations, and renewals. Your duties will involve staying abreast of evolving regulatory landscapes, providing expert advice to cross-functional teams (e.g., R&D, Clinical Operations, Quality Assurance), and managing regulatory submissions throughout their lifecycle. You will conduct regulatory intelligence activities, assess the impact of new regulations, and contribute to the development of regulatory strategies. The ideal candidate will have a strong scientific background, typically with a degree in a life science, chemistry, pharmacy, or a related field, and a minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry. Proven experience with major regulatory agencies (e.g., FDA, EMA, MHRA) and knowledge of ICH guidelines are essential. Excellent written and verbal communication skills, meticulous attention to detail, and strong project management abilities are required. You should be adept at navigating complex regulatory frameworks and effectively communicating scientific and regulatory information. This position offers a stimulating environment where you can contribute significantly to bringing essential medicines to patients worldwide.
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3
Senior Regulatory Affairs Specialist
622 Gudaibiya, Capital
BHD90000 Annually
WhatJobs
Posted 3 days ago
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Job Description
Our client, a leading innovator in the (mention relevant industry, e.g., technology, healthcare) sector, is seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join their expanding team. This is a fully remote position, offering the opportunity to contribute to critical projects from anywhere. The ideal candidate will possess a comprehensive understanding of regulatory frameworks, compliance strategies, and submission processes relevant to our industry. You will play a crucial role in ensuring our products and services meet all necessary legal and regulatory requirements, facilitating market entry and ongoing compliance.
Key Responsibilities:
Qualifications:
This fully remote role offers the chance to significantly impact regulatory strategy and compliance from your home office.
Key Responsibilities:
- Develop and implement regulatory strategies for new and existing products/services in alignment with global compliance standards.
- Prepare, review, and submit regulatory documentation to relevant authorities (e.g., FDA, EMA, local regulatory bodies).
- Interpret and communicate complex regulatory requirements to internal teams, including R&D, product development, and marketing.
- Monitor changes in regulatory landscapes and proactively assess their impact on the company's operations and product portfolio.
- Act as the primary point of contact with regulatory agencies, managing communications and addressing inquiries.
- Conduct regulatory audits and ensure internal compliance with established procedures and guidelines.
- Identify potential regulatory risks and develop mitigation strategies.
- Collaborate with cross-functional teams to ensure product development and manufacturing processes adhere to regulatory standards.
- Maintain accurate and organized regulatory records and databases.
- Contribute to the development of regulatory policies and standard operating procedures (SOPs).
- Provide training and guidance to internal stakeholders on regulatory matters.
- Support post-market surveillance activities and manage regulatory reporting requirements.
Qualifications:
- Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
- Minimum of 6 years of progressive experience in regulatory affairs, preferably within the (mention relevant industry) sector.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global regulatory requirements and guidelines pertinent to our industry.
- Excellent understanding of product lifecycle management and associated regulatory considerations.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly and persuasively.
- Proficiency in regulatory information management systems and relevant software.
- Ability to work independently, manage priorities effectively, and meet tight deadlines in a remote environment.
- Detail-oriented with a high degree of accuracy.
- Experience in international regulatory affairs is a significant advantage.
This fully remote role offers the chance to significantly impact regulatory strategy and compliance from your home office.
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4
Pharmaceutical Regulatory Affairs Specialist
800 Southern, Southern
BHD85000 Annually
WhatJobs
Posted 5 days ago
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Job Description
Our client, a rapidly growing pharmaceutical company, is seeking a dedicated Pharmaceutical Regulatory Affairs Specialist to join their dynamic team. This role offers the flexibility of being fully remote. You will be responsible for ensuring compliance with regulatory requirements for the development, manufacturing, and marketing of pharmaceutical products. Your duties will include preparing and submitting regulatory dossiers to health authorities, responding to regulatory inquiries, and staying updated on evolving regulatory landscapes and guidelines in key markets. You will play a crucial role in facilitating the timely approval of new drug applications and post-approval variations. The ideal candidate will possess a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific field, with a minimum of 5 years of experience in pharmaceutical regulatory affairs. Proven experience in preparing and filing regulatory submissions (e.g., INDs, NDAs, MAAs) with major health authorities (FDA, EMA, etc.) is essential. Strong understanding of pharmaceutical regulations, ICH guidelines, and GMP principles is required. Excellent written and verbal communication skills, meticulous attention to detail, and strong organizational abilities are crucial. The ability to work independently, manage multiple projects, and collaborate effectively with internal teams (R&D, Quality Assurance, Marketing) and external regulatory agencies in a remote setting is paramount. We are looking for a proactive professional committed to ensuring patient access to high-quality medicines through effective regulatory strategies.
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5
Lead Regulatory Affairs Specialist
321 Zallaq, Southern
BHD95000 Annually
WhatJobs
Posted 9 days ago
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Job Description
Our client is a rapidly growing biotechnology firm looking for a proactive and detail-oriented Lead Regulatory Affairs Specialist to join their fully remote team. This position is critical in ensuring that our client's innovative products meet global regulatory standards, facilitating successful market entry and ongoing compliance. You will be responsible for developing and implementing regulatory strategies, preparing submission dossiers, and liaising with health authorities worldwide.
Responsibilities:
Responsibilities:
- Develop and execute regulatory strategies for product development and registration, encompassing global markets.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities such as the FDA, EMA, and others.
- Interpret and communicate regulatory requirements and guidelines to internal teams.
- Manage post-approval regulatory activities, including amendments, supplements, and annual reports.
- Conduct regulatory intelligence activities to stay abreast of evolving regulations and advise the company accordingly.
- Liaise with regulatory agencies during the review process and respond to queries.
- Ensure compliance with Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
- Collaborate closely with R&D, quality assurance, clinical operations, and commercial teams.
- Develop and maintain regulatory documentation and databases.
- Provide training on regulatory compliance to relevant personnel.
- Participate in regulatory audits and inspections.
- Bachelor's degree in a life science, chemistry, pharmacy, or related field; advanced degree preferred.
- Minimum of 6 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Proven success in preparing and filing successful regulatory submissions for drugs or medical devices.
- In-depth knowledge of international regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
- Strong understanding of the drug development process and relevant scientific disciplines.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Exceptional attention to detail and organizational skills.
- Proficiency in regulatory information management systems.
- Ability to work independently and collaboratively in a remote team environment.
- Strong problem-solving skills and strategic thinking.
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6
Senior Regulatory Affairs Counsel
310 Northern, Northern
BHD130000 Annually
WhatJobs
Posted 10 days ago
Job Viewed
Job Description
Our client, a leader in the (mention industry, e.g., pharmaceutical, technology) sector, is seeking a highly specialized Senior Regulatory Affairs Counsel to join their sophisticated, fully remote legal department. This role is critical for navigating the complex and evolving regulatory landscape, ensuring the company's compliance and strategic market access. You will provide expert legal counsel on regulatory matters, advise on policy development, and manage interactions with regulatory bodies. The ideal candidate possesses deep knowledge of regulatory frameworks, exceptional analytical skills, and the ability to translate complex legal requirements into practical business solutions within a virtual team setting.
Key Responsibilities:
Qualifications:
This is a significant opportunity for a senior legal professional to play a pivotal role in shaping the regulatory strategy of a leading organization, enjoying the benefits of a fully remote work arrangement. You will contribute directly to the company's ability to bring innovative products to market safely and compliantly. This role supports the company's operations and regulatory strategy relevant to Shakhura, Northern, BH , and globally, entirely remotely.
Key Responsibilities:
- Provide strategic legal advice on all aspects of regulatory affairs, including product approvals, labeling, advertising, and post-market surveillance.
- Interpret and advise on applicable laws, regulations, guidelines, and standards in relevant jurisdictions.
- Develop and implement regulatory strategies to support product launches and market expansion.
- Review and approve promotional materials and other communications for regulatory compliance.
- Liaise with regulatory agencies (e.g., FDA, EMA, local authorities) on behalf of the company.
- Manage regulatory submissions, applications, and interactions.
- Conduct regulatory risk assessments and advise on mitigation strategies.
- Develop and deliver training on regulatory compliance to internal stakeholders.
- Stay abreast of emerging regulatory trends, legislative changes, and industry best practices.
- Collaborate with R&D, product development, marketing, and other teams to ensure regulatory considerations are integrated into business decisions.
- Manage external counsel and consultants involved in regulatory matters.
Qualifications:
- Juris Doctor (JD) or equivalent law degree from a reputable institution.
- Admission to the bar and in good standing in a relevant jurisdiction.
- Minimum of 8 years of experience in regulatory affairs law, preferably within the (mention specific industry) sector.
- In-depth understanding of the regulatory framework governing (mention specific products or services, e.g., pharmaceuticals, medical devices, financial products).
- Proven experience interacting with regulatory agencies and managing submissions.
- Excellent analytical, research, and problem-solving skills.
- Strong written and verbal communication skills, with the ability to articulate complex legal and regulatory issues clearly.
- Ability to work independently, manage multiple priorities, and meet demanding deadlines in a remote environment.
- Experience with (mention specific regulatory processes or compliance areas) is highly desirable.
- High ethical standards and a commitment to compliance.
This is a significant opportunity for a senior legal professional to play a pivotal role in shaping the regulatory strategy of a leading organization, enjoying the benefits of a fully remote work arrangement. You will contribute directly to the company's ability to bring innovative products to market safely and compliantly. This role supports the company's operations and regulatory strategy relevant to Shakhura, Northern, BH , and globally, entirely remotely.
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7
Senior Regulatory Affairs Specialist
101 Bilad Al Qadeem, Capital
BHD90000 Annually
WhatJobs
Posted 13 days ago
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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.
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8
Regulatory Affairs Specialist - Pharmaceutical
8765 Seef, Capital
BHD70000 Annually
WhatJobs
Posted 15 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.
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