Explore regulatory affairs specialist positions, where professionals ensure 35 Regulatory Affairs Specialist jobs in Bahrain
Regulatory Affairs Specialist
3001 Northern, Northern
BHD5000 Monthly
WhatJobs
Posted 9 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 15 days ago
Job Viewed
Job Description
Our client is seeking a meticulous and knowledgeable Regulatory Affairs Specialist to ensure compliance with all relevant industry regulations and standards. This role is vital for navigating the complex regulatory landscape and facilitating the smooth market entry and lifecycle management of our client's products. The ideal candidate will have a thorough understanding of regulatory requirements, submission processes, and quality management systems. You will be responsible for preparing, reviewing, and submitting regulatory documentation to health authorities and other regulatory bodies. This includes developing regulatory strategies, advising on compliance requirements, and managing regulatory submissions throughout their lifecycle.
Key responsibilities include monitoring changes in regulations and guidelines, assessing their impact on the company's products and operations, and implementing necessary changes. You will work closely with R&D, quality assurance, and marketing teams to ensure that all activities and products are compliant. The role demands strong analytical skills, excellent written and verbal communication, and the ability to interpret and apply complex regulatory texts. Experience with regulatory databases and documentation management systems is essential. Maintaining strong relationships with regulatory agencies is also a key aspect of this position. The successful candidate will have a Bachelor's degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) or a related discipline, with at least 5 years of experience in regulatory affairs, preferably within a regulated industry. Knowledge of international regulatory requirements is highly advantageous. This role offers a hybrid work arrangement, combining office-based collaboration with remote flexibility, based in **Saar, Northern, BH**. Join our client and play a critical role in their regulatory success.
Key responsibilities include monitoring changes in regulations and guidelines, assessing their impact on the company's products and operations, and implementing necessary changes. You will work closely with R&D, quality assurance, and marketing teams to ensure that all activities and products are compliant. The role demands strong analytical skills, excellent written and verbal communication, and the ability to interpret and apply complex regulatory texts. Experience with regulatory databases and documentation management systems is essential. Maintaining strong relationships with regulatory agencies is also a key aspect of this position. The successful candidate will have a Bachelor's degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) or a related discipline, with at least 5 years of experience in regulatory affairs, preferably within a regulated industry. Knowledge of international regulatory requirements is highly advantageous. This role offers a hybrid work arrangement, combining office-based collaboration with remote flexibility, based in **Saar, Northern, BH**. Join our client and play a critical role in their regulatory success.
This advertiser has chosen not to accept applicants from your region.
1
Senior Regulatory Affairs Specialist
123 Galali
BHD115000 Annually
WhatJobs
Posted 4 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.
2
Senior Regulatory Affairs Specialist
10001 Tubli
BHD85000 Annually
WhatJobs
Posted 9 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.
3
Pharmaceutical Regulatory Affairs Specialist
703 Hamad Town, Northern
BHD70000 Annually
WhatJobs
Posted 12 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.
4
Pharmaceutical Regulatory Affairs Specialist
400 Seef, Capital
BHD7000 Monthly
WhatJobs
Posted 14 days ago
Job Viewed
Job Description
Our client is seeking an experienced Pharmaceutical Regulatory Affairs Specialist to join their team at their offices in Seef, Capital, BH . This role is essential for navigating the complex regulatory landscape of pharmaceutical product development and marketing. The successful candidate will be responsible for ensuring that all company products comply with relevant national and international regulations, preparing and submitting regulatory dossiers, and liaising with health authorities. This position requires a meticulous approach, excellent attention to detail, and a strong understanding of pharmaceutical guidelines.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Interpreting and applying regulatory guidelines and legislation to company products.
- Preparing, reviewing, and submitting regulatory documentation (e.g., CTD, ANDA, NDA) to health authorities.
- Liaising with regulatory agencies to facilitate product approvals and address queries.
- Monitoring changes in regulatory requirements and assessing their impact on the business.
- Ensuring compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Managing post-approval regulatory activities, including variations, renewals, and annual reports.
- Providing regulatory support and guidance to R&D, manufacturing, and marketing departments.
- Assessing the regulatory strategy for new product development projects.
- Maintaining regulatory databases and filing systems.
- Participating in regulatory audits and inspections.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree is preferred.
- Minimum of 4 years of direct experience in pharmaceutical regulatory affairs.
- In-depth knowledge of Bahraini and relevant international regulatory requirements (e.g., FDA, EMA).
- Proven experience in preparing and submitting regulatory dossiers.
- Excellent understanding of the pharmaceutical product lifecycle.
- Strong analytical, research, and problem-solving skills.
- Exceptional written and verbal communication skills, with a high level of accuracy.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
- Proficiency in regulatory information management systems is an advantage.
- Detail-oriented with strong organizational skills.
This advertiser has chosen not to accept applicants from your region.
5
Senior Regulatory Affairs Specialist
40001 Al Daih, Northern
BHD95000 Annually
WhatJobs
Posted 15 days ago
Job Viewed
Job Description
Our client, a well-established player in the highly regulated pharmaceutical industry, is seeking an experienced Senior Regulatory Affairs Specialist to join their team. This role offers a hybrid work model, blending remote flexibility with essential in-office collaboration. The ideal candidate will possess a deep understanding of global regulatory requirements and a proven ability to navigate complex submission processes. You will be responsible for ensuring that our client's products comply with all applicable regulations, from development through post-market surveillance, playing a critical role in bringing innovative therapies to market.
Responsibilities:
Responsibilities:
- Develop and implement regulatory strategies for product registration and lifecycle management in various global markets.
- Prepare, review, and submit regulatory documentation (e.g., INDs, NDAs, MAAs, supplements) to health authorities.
- Liaise with regulatory agencies (e.g., FDA, EMA) to facilitate communication and address inquiries.
- Interpret and advise on the impact of evolving regulatory guidelines and requirements.
- Conduct regulatory intelligence activities to stay ahead of industry changes.
- Ensure compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP).
- Collaborate closely with R&D, Quality Assurance, and Commercial teams to ensure alignment on regulatory matters.
- Manage post-approval regulatory activities, including annual reports and variations.
- Assess the regulatory acceptability of promotional materials and labeling.
- Lead regulatory inspections and audits.
- Contribute to the development of departmental policies and procedures.
- Bachelor's or Master's degree in a scientific discipline (e.g., Pharmacy, Biology, Chemistry).
- Minimum of 8 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory requirements in key markets (e.g., US, EU, Japan).
- Proven experience in preparing and submitting major regulatory filings.
- Strong understanding of drug development processes and product lifecycle management.
- Excellent analytical, written, and verbal communication skills.
- Ability to manage multiple projects and meet tight deadlines.
- Experience with regulatory information management systems is desirable.
- Strong interpersonal skills for effective collaboration with internal teams and external agencies.
- Demonstrated ability to work effectively in a hybrid work environment.
This advertiser has chosen not to accept applicants from your region.
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6
Senior Regulatory Affairs Specialist
621 Isa Town, Northern
BHD90000 Annually
WhatJobs
Posted 17 days ago
Job Viewed
Job Description
Our client is looking for an experienced and dedicated Senior Regulatory Affairs Specialist to join their remote team. This crucial role involves ensuring that all products and operations comply with relevant national and international regulations. You will be responsible for interpreting complex regulatory requirements, developing strategies for compliance, and preparing submissions for regulatory bodies. The ideal candidate will possess a deep understanding of the regulatory landscape specific to our client's industry and a proven track record of successfully navigating regulatory processes. Responsibilities include staying abreast of evolving regulations, conducting regulatory impact assessments, and collaborating with R&D, manufacturing, and quality assurance departments to ensure adherence. You will also manage regulatory documentation, maintain compliance records, and participate in regulatory audits. This position requires exceptional analytical skills, meticulous attention to detail, and strong communication abilities, enabling you to effectively liaise with regulatory agencies and internal stakeholders. As a fully remote position, you will need to be self-motivated, highly organized, and proficient in using virtual collaboration tools. We seek a proactive individual who can identify potential regulatory challenges and implement effective solutions, safeguarding the company's market access and reputation. This is a key opportunity to contribute to product development and market compliance from a flexible, remote environment.
Responsibilities:
Responsibilities:
- Interpret and apply complex regulatory requirements to products and processes.
- Develop and implement regulatory strategies for product approvals and market access.
- Prepare and submit regulatory documentation to health authorities and other agencies.
- Monitor and analyze changes in regulatory legislation and guidance.
- Conduct regulatory impact assessments for new product development and post-market changes.
- Liaise with regulatory agencies, responding to inquiries and facilitating communications.
- Collaborate with R&D, Quality Assurance, and Manufacturing teams to ensure compliance.
- Maintain regulatory compliance records and databases.
- Support regulatory audits and inspections.
- Advise on regulatory aspects of product lifecycle management.
- Bachelor's degree in a scientific, technical, or related field. Advanced degree preferred.
- Minimum of 6-8 years of progressive experience in regulatory affairs.
- In-depth knowledge of relevant national and international regulatory requirements.
- Proven experience in preparing and submitting regulatory dossiers.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills.
- Proficiency in regulatory information management systems.
- Ability to work independently and manage multiple projects effectively.
- Strong organizational skills and meticulous attention to detail.
- Experience with remote work environments and virtual collaboration tools.
This advertiser has chosen not to accept applicants from your region.
7
Senior Regulatory Affairs Specialist - Pharmaceuticals
1002 Al Seef
BHD90000 Annually
WhatJobs
Posted 1 day ago
Job Viewed
Job Description
Our client is seeking an experienced Senior Regulatory Affairs Specialist to join their dynamic pharmaceutical team in Salmabad, Northern, BH . This critical role involves ensuring that all products comply with national and international regulatory requirements throughout their lifecycle. The ideal candidate will have a profound understanding of pharmaceutical regulations, submission processes, and quality standards. You will be responsible for preparing, reviewing, and submitting regulatory dossiers for new drug applications, variations, and renewals. Key duties include interpreting regulatory guidelines, liaising with health authorities, and collaborating with internal departments such as R&D, Clinical Affairs, and Quality Assurance to ensure strategic alignment. This position demands exceptional attention to detail, strong analytical skills, and the ability to manage multiple projects simultaneously. You will stay abreast of evolving regulatory landscapes and provide expert guidance to project teams. We are looking for a proactive individual who can navigate complex regulatory environments, anticipate challenges, and develop effective strategies to achieve timely approvals. This role offers significant opportunities for professional growth and impact within a leading pharmaceutical organization. If you possess a strong regulatory background and a passion for bringing life-saving medicines to market, we encourage you to apply.
Responsibilities:
Responsibilities:
- Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals.
- Ensure compliance with all relevant pharmaceutical regulations and guidelines (e.g., FDA, EMA, ICH).
- Serve as the primary point of contact with regulatory health authorities.
- Collaborate with internal departments (R&D, Clinical, QA, Manufacturing) to gather necessary information and ensure regulatory compliance.
- Interpret and communicate regulatory requirements and changes to relevant stakeholders.
- Conduct regulatory intelligence activities to stay updated on evolving legislation.
- Manage the lifecycle of regulatory submissions and approvals.
- Participate in regulatory strategy development for new product initiatives.
- Review marketing materials and product labeling for regulatory compliance.
- Support regulatory audits and inspections.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- Thorough knowledge of global regulatory requirements and submission processes.
- Experience preparing and submitting dossiers (e.g., CTD format).
- Strong understanding of drug development processes and pharmaceutical manufacturing.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills.
- Ability to manage multiple complex projects and meet strict deadlines.
- Proficiency in regulatory information management systems is a plus.
- Detail-oriented with strong organizational skills.
This advertiser has chosen not to accept applicants from your region.
8
Senior Regulatory Affairs Specialist - Pharmaceutical
211 Ghuraifa, Capital
BHD78000 Annually
WhatJobs
Posted 2 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their team in Jidhafs, Capital, BH . This pivotal role is responsible for ensuring compliance with global regulatory requirements for pharmaceutical products. The position offers a hybrid work model, blending essential on-site collaboration with remote flexibility.
Responsibilities:
Qualifications:
This is an excellent opportunity to contribute to the advancement of healthcare by ensuring the timely availability of safe and effective medicines. Our client offers a competitive salary, comprehensive benefits, and a dynamic work environment. Join our team and make a difference in Jidhafs, Capital, BH .
Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
- Develop and implement regulatory strategies for new drug applications and product lifecycle management.
- Interpret and advise on regulatory guidelines and requirements from agencies such as FDA, EMA, and others.
- Maintain regulatory compliance for existing products, including post-approval changes and annual reports.
- Liaise with health authorities, regulatory agencies, and internal departments to ensure timely and successful approvals.
- Evaluate regulatory intelligence and assess its impact on company products and strategies.
- Collaborate with R&D, clinical affairs, manufacturing, and quality assurance teams to ensure regulatory requirements are met throughout the product development process.
- Manage responses to regulatory agency queries and audits.
- Develop and maintain regulatory filing systems and databases.
- Provide training and guidance to internal stakeholders on regulatory affairs matters.
- Contribute to the development of SOPs related to regulatory processes.
- Monitor industry trends and changes in pharmaceutical regulations.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or Ph.D. is advantageous.
- Minimum of 5-7 years of progressive experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of global regulatory requirements and submission processes for pharmaceuticals.
- Proven experience in preparing and submitting regulatory dossiers.
- Strong understanding of drug development processes, manufacturing, and quality systems.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Proficiency in regulatory information management systems.
- Ability to work independently and collaboratively in a hybrid work environment.
- High ethical standards and attention to detail.
- Strong project management skills and the ability to manage multiple projects concurrently.
This is an excellent opportunity to contribute to the advancement of healthcare by ensuring the timely availability of safe and effective medicines. Our client offers a competitive salary, comprehensive benefits, and a dynamic work environment. Join our team and make a difference in Jidhafs, Capital, BH .
This advertiser has chosen not to accept applicants from your region.
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