138 Regulatory Affairs Specialist jobs in Bahrain
Regulatory Affairs Specialist
Posted 11 days ago
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Pharmaceutical Regulatory Affairs Specialist
Posted today
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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**.
Senior Regulatory Affairs Specialist
Posted 3 days ago
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Senior Regulatory Affairs Specialist
Posted 3 days ago
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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.
Pharmaceutical Regulatory Affairs Specialist
Posted 5 days ago
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Lead Regulatory Affairs Specialist
Posted 10 days ago
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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.
Senior Regulatory Affairs Specialist
Posted 13 days ago
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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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Regulatory Affairs Specialist - Pharmaceutical
Posted 15 days ago
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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.
Senior Regulatory Affairs Specialist
Posted 17 days ago
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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.
Senior Regulatory Affairs Specialist
Posted 17 days ago
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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.