Explore regulatory affairs specialist positions, where professionals ensure 138 Regulatory Affairs Specialist jobs in Bahrain
Regulatory Affairs Specialist
23456 Al Ghurayfah
BHD105000 Annually
WhatJobs
Posted 11 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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Pharmaceutical Regulatory Affairs Specialist
1015 Northern, Northern
BHD70000 Annually
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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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1
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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2
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.
This advertiser has chosen not to accept applicants from your region.
3
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.
This advertiser has chosen not to accept applicants from your region.
4
Lead Regulatory Affairs Specialist
321 Zallaq, Southern
BHD95000 Annually
WhatJobs
Posted 10 days ago
Job Viewed
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.
This advertiser has chosen not to accept applicants from your region.
5
Senior Regulatory Affairs Specialist
101 Bilad Al Qadeem, Capital
BHD90000 Annually
WhatJobs
Posted 13 days ago
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.
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6
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.
This advertiser has chosen not to accept applicants from your region.
7
Senior Regulatory Affairs Specialist
8372 Hamad Town, Northern
BHD95000 Annually
WhatJobs
Posted 17 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.
8
Senior Regulatory Affairs Specialist
228 Muharraq, Muharraq
BHD100000 Annually
WhatJobs
Posted 17 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.
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