234 Regulatory Affairs Specialists jobs in Bahrain
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.
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0
Regulatory Affairs Specialist
67890 Saar, Northern
BHD90000 Annually
WhatJobs
Posted 6 days ago
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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.
1
Regulatory Affairs Specialist - Pharmaceutical
8765 Seef, Capital
BHD70000 Annually
WhatJobs
Posted 1 day 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.
2
Senior Regulatory Affairs Specialist
8372 Hamad Town, Northern
BHD95000 Annually
WhatJobs
Posted 3 days ago
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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.
3
Senior Regulatory Affairs Specialist
228 Muharraq, Muharraq
BHD100000 Annually
WhatJobs
Posted 3 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.
4
Senior Regulatory Affairs Specialist
101 Bilad Al Qadeem, Capital
BHD85000 Annually
WhatJobs
Posted 4 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.
5
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.
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6
Senior Regulatory Affairs Specialist
123 Galali
BHD115000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client is a leading innovator in the pharmaceutical industry, committed to bringing life-changing medicines to market. We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our dedicated team. This role is crucial for ensuring compliance with global regulatory requirements throughout the product lifecycle, from early development to post-market surveillance. The ideal candidate will possess a strong understanding of regulatory submission processes, excellent communication skills, and a meticulous attention to detail. You will play a key role in shaping regulatory strategies, preparing submission dossiers, and liaising with health authorities. This position requires a proactive approach, a commitment to quality, and the ability to navigate complex regulatory landscapes effectively. The successful candidate will collaborate closely with R&D, clinical, manufacturing, and commercial teams. Responsibilities:
- Develop and implement regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, CTAs) to global health authorities.
- Liaise directly with regulatory agencies (e.g., FDA, EMA, HSA) to facilitate submissions and respond to queries.
- Provide regulatory guidance and input to cross-functional teams throughout the product development process.
- Monitor and interpret evolving regulatory guidelines and advise the organization on compliance requirements.
- Assess the regulatory implications of product changes, manufacturing processes, and labeling updates.
- Manage regulatory compliance activities, including annual reports and post-approval supplements.
- Conduct regulatory due diligence for potential business development opportunities.
- Maintain regulatory documentation and databases.
- Represent the company in interactions with regulatory bodies and industry associations.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Master's degree or equivalent experience preferred.
- Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Proven experience in preparing and submitting various regulatory filings in major markets.
- In-depth knowledge of global regulatory guidelines (e.g., ICH, FDA, EMA regulations).
- Strong understanding of drug development processes, clinical trials, and GMP/GDP requirements.
- Excellent written and verbal communication skills, with a strong command of scientific and regulatory terminology.
- Meticulous attention to detail and strong organizational skills.
- Ability to work independently and as part of a collaborative team.
- Proficiency in regulatory information management systems is a plus.
- Strong analytical and problem-solving abilities.
This advertiser has chosen not to accept applicants from your region.
7
Senior Regulatory Affairs Specialist
10001 Tubli
BHD85000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client, a leading player in its industry, is seeking a highly qualified Senior Regulatory Affairs Specialist to ensure compliance with all relevant national and international regulations. This crucial role involves developing and implementing regulatory strategies, preparing and submitting regulatory documentation, and liaising with regulatory authorities. You will be responsible for staying abreast of evolving regulatory landscapes, assessing the impact of new regulations on the company's products and processes, and providing expert guidance to internal teams. Key responsibilities include conducting regulatory reviews of product labeling and marketing materials, managing regulatory submissions, and overseeing post-market surveillance activities. The ideal candidate possesses a strong understanding of regulatory affairs principles, excellent analytical and problem-solving skills, and exceptional attention to detail. Proven experience in navigating complex regulatory environments is essential. You will work collaboratively with R&D, quality assurance, and legal departments to ensure that all products and operations meet the highest standards of regulatory compliance. A Bachelor's degree in a relevant scientific or technical field is required, with advanced degrees or certifications in regulatory affairs being a significant advantage. Significant experience in regulatory affairs, demonstrating successful management of regulatory submissions and compliance activities, is mandatory. We are looking for a meticulous and proactive professional who can effectively manage regulatory risks and contribute to the company's continued success.
This advertiser has chosen not to accept applicants from your region.
8
Pharmaceutical Regulatory Affairs Specialist
703 Hamad Town, Northern
BHD70000 Annually
WhatJobs
Posted 6 days ago
Job Viewed
Job Description
Our client is actively seeking a dedicated and experienced Pharmaceutical Regulatory Affairs Specialist to join their innovative team in Hamad Town, Northern, BH . This critical role is responsible for ensuring that all pharmaceutical products developed and marketed by the company comply with national and international regulatory requirements. You will manage the preparation, submission, and maintenance of regulatory filings, including marketing authorization applications, variations, and renewals. The ideal candidate will possess a deep understanding of pharmaceutical regulations, a strong command of regulatory submission processes, and excellent communication skills.
You will serve as a key liaison between the company and regulatory authorities, building and maintaining strong relationships. Responsibilities include interpreting complex regulatory guidelines, providing strategic regulatory advice to product development teams, and ensuring that labeling and promotional materials meet all legal and ethical standards. The ability to stay abreast of evolving regulatory landscapes and to proactively identify and address potential compliance issues is paramount. This role is essential for facilitating the timely approval and continued market access of our client's life-saving medications.
Key Responsibilities:
Qualifications:
This on-site position is based in Hamad Town, Northern, BH .
You will serve as a key liaison between the company and regulatory authorities, building and maintaining strong relationships. Responsibilities include interpreting complex regulatory guidelines, providing strategic regulatory advice to product development teams, and ensuring that labeling and promotional materials meet all legal and ethical standards. The ability to stay abreast of evolving regulatory landscapes and to proactively identify and address potential compliance issues is paramount. This role is essential for facilitating the timely approval and continued market access of our client's life-saving medications.
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., CTD, eCTD) for new drug applications, variations, and renewals in various global markets.
- Interpret and communicate complex regulatory guidelines and requirements to internal stakeholders.
- Liaise with regulatory agencies (e.g., local health authorities) to facilitate the approval process and respond to inquiries.
- Ensure that product labeling, packaging, and promotional materials comply with all applicable regulations.
- Provide regulatory strategic guidance to R&D, clinical, and manufacturing departments throughout the product lifecycle.
- Monitor changes in the regulatory landscape and assess their impact on company products and strategies.
- Maintain regulatory databases and ensure accurate record-keeping.
- Participate in regulatory inspections and audits.
- Collaborate with cross-functional teams to ensure regulatory compliance.
- Advise on regulatory strategies for product lifecycle management and post-approval activities.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 4 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulations and submission processes.
- Proven experience in preparing and submitting marketing authorization applications.
- Familiarity with eCTD publishing software and regulatory information management systems.
- Excellent written and verbal communication skills, with the ability to write clear and concise regulatory documents.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
- Detail-oriented with a high degree of accuracy.
- Team player with strong interpersonal skills.
This on-site position is based in Hamad Town, Northern, BH .
This advertiser has chosen not to accept applicants from your region.
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