48 Regulatory Submissions jobs in Bahrain
Pharmaceutical Regulatory Affairs Manager
Posted 1 day ago
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Pharmaceutical Regulatory Affairs Specialist
Posted 12 days ago
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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 .
Pharmaceutical Regulatory Affairs Specialist
Posted 14 days ago
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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.
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 3 days ago
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Key responsibilities include:
- Developing and implementing regulatory strategies for product registration and lifecycle management.
- Preparing and submitting regulatory documentation, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and variations.
- Liaising with regulatory authorities (e.g., FDA, EMA, local health authorities) to facilitate the approval process.
- Interpreting and communicating complex regulatory requirements to internal teams, including R&D, manufacturing, and marketing.
- Conducting regulatory due diligence for potential product acquisitions or partnerships.
- Monitoring changes in regulatory landscapes and assessing their impact on the company's products and operations.
- Ensuring that all promotional materials and advertising comply with regulatory guidelines.
- Developing and delivering regulatory training to relevant personnel.
- Managing post-market surveillance activities and reporting adverse events.
- Contributing to the development of company policies and procedures to ensure ongoing regulatory compliance.
The ideal candidate will hold a Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field, with a minimum of 5 years of experience in pharmaceutical regulatory affairs. A Master's degree or advanced degree is a plus. Thorough knowledge of global regulatory guidelines and submission processes is essential. Excellent written and verbal communication skills, strong analytical abilities, and meticulous attention to detail are required. Experience with regulatory information management systems is beneficial. This role supports our client’s operations in **Hidd, Muharraq, BH**.
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 3 days ago
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- Preparing, reviewing, and submitting regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
- Ensuring all regulatory submissions are accurate, complete, and compliant with relevant guidelines and regulations.
- Monitoring and interpreting changes in regulatory legislation and advising internal teams accordingly.
- Managing post-approval lifecycle activities, including variations, annual reports, and renewals.
- Liaising with regulatory agencies on submission-related inquiries and responses.
- Collaborating with R&D, manufacturing, and quality departments to gather necessary information for submissions.
- Developing and implementing regulatory strategies for product development and registration.
- Reviewing promotional materials for regulatory compliance.
- Maintaining regulatory databases and tracking submission status.
- Providing regulatory support and guidance to project teams.
- Ensuring timely approval of products in target markets.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
- Minimum of 3-5 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting common technical documents (CTD) and other regulatory filings.
- In-depth knowledge of global pharmaceutical regulations (e.g., FDA, EMA, PMDA).
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to work independently and manage multiple projects simultaneously in a remote setting.
- Proficiency in regulatory information management systems.
- Strong analytical and problem-solving abilities.
- Experience in specific therapeutic areas is a plus.
- This role is 100% remote, offering flexibility and work-life balance.
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 4 days ago
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Remote Pharmaceutical Regulatory Affairs Specialist
Posted 7 days ago
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Responsibilities:
- Prepare, review, and submit regulatory filings (e.g., IND, NDA, ANDA, supplements) to global health authorities.
- Interpret and apply regulatory guidelines and requirements from FDA, EMA, and other agencies.
- Develop and execute regulatory strategies for drug development programs.
- Manage regulatory agency communications and respond to inquiries.
- Collaborate with cross-functional teams to ensure alignment on regulatory requirements.
- Review and approve regulatory labeling and promotional materials.
- Maintain regulatory databases and tracking systems.
- Conduct regulatory intelligence gathering and analysis.
- Support regulatory inspections and audits.
- Provide guidance on regulatory compliance matters to internal teams.
- Assess the regulatory impact of product changes and manufacturing processes.
- Bachelor's degree in Pharmacy, Chemistry, Biology, Life Sciences, or a related field. A Master's or Pharm.D. is preferred.
- Minimum of 5 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of FDA regulations (e.g., cGMP, GCP, GLP) and ICH guidelines.
- Proven experience in preparing and submitting various regulatory dossiers.
- Excellent understanding of drug development processes from preclinical to post-market.
- Strong analytical, problem-solving, and critical-thinking skills.
- Exceptional written and verbal communication and interpersonal skills.
- Ability to manage multiple projects and meet strict deadlines.
- Proficiency in regulatory information management systems (RIMS) is a plus.
- Ability to work independently and effectively in a remote environment.
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Remote Pharmaceutical Regulatory Affairs Specialist
Posted 9 days ago
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Key Responsibilities:
- Prepare, review, and submit regulatory dossiers and applications to health authorities worldwide (e.g., FDA, EMA, MHRA).
- Interpret and apply regulatory guidelines and regulations to product development and manufacturing processes.
- Monitor changes in the regulatory landscape and assess their impact on company products and strategies.
- Liaise with health authorities during the review process, responding to queries and providing additional information as needed.
- Develop and maintain regulatory strategies for new product development and lifecycle management.
- Collaborate with R&D, Quality Assurance, Manufacturing, and Marketing departments to ensure regulatory compliance.
- Review and approve promotional materials and labeling to ensure accuracy and compliance.
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Conduct regulatory intelligence gathering and disseminate relevant information to stakeholders.
- Ensure all regulatory documentation is accurate, complete, and submitted in a timely manner.
- Contribute to the development and improvement of departmental SOPs and work instructions.
- Maintain a high level of organization and attention to detail in managing complex regulatory projects.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field; advanced degree or regulatory affairs certification (e.g., RAC) is a strong asset.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successfully preparing and submitting regulatory dossiers for various markets.
- In-depth knowledge of global regulatory requirements for pharmaceuticals (e.g., ICH guidelines, FDA regulations, EU directives).
- Experience with electronic submission platforms (e.g., eCTD).
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Strong analytical and problem-solving skills.
- Ability to manage multiple projects simultaneously and meet tight deadlines.
- Proficiency in regulatory information management systems and Microsoft Office Suite.
- Self-motivated, organized, and able to work independently in a remote environment.
- Must have a dedicated home office setup conducive to remote work and reliable internet access.
This remote position offers a significant opportunity to make a direct impact on bringing essential medicines to market and ensuring patient safety. If you are a dedicated regulatory affairs professional seeking a challenging remote role, we encourage you to apply.
Senior Pharmaceutical Regulatory Affairs Manager
Posted 10 days ago
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Key responsibilities include:
- Developing and implementing global regulatory strategies for new drug applications (NDAs), abbreviated new drug applications (ANDAs), and other regulatory submissions.
- Preparing, reviewing, and submitting comprehensive regulatory dossiers to health authorities such as the FDA, EMA, and others.
- Interpreting and applying global regulatory guidelines, ensuring company-wide compliance.
- Managing regulatory submissions throughout their lifecycle, including responding to health authority queries and post-approval changes.
- Serving as a primary point of contact for regulatory agencies, building and maintaining positive relationships.
- Collaborating with R&D, clinical, manufacturing, and marketing teams to ensure regulatory requirements are integrated into product development and commercialization plans.
- Conducting regulatory intelligence activities to stay abreast of evolving regulations and guidelines.
- Assessing the regulatory impact of proposed product changes and marketing strategies.
- Providing regulatory guidance and training to internal teams.
- Leading regulatory project teams and ensuring timely completion of regulatory milestones.
The successful candidate will hold a Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology), with a minimum of 8 years of progressive experience in pharmaceutical regulatory affairs. Extensive experience with regulatory submissions in major global markets (US, Europe, etc.) is mandatory. Strong knowledge of ICH guidelines and regional regulatory requirements is essential. Excellent written and verbal communication skills, with the ability to clearly articulate complex regulatory issues, are critical. This is an exceptional opportunity to take on a leadership role in regulatory affairs within a forward-thinking organization, contributing significantly to bringing life-changing medicines to patients globally, all from your remote work environment near **Salmabad, Northern, BH**.
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 15 days ago
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Key responsibilities include interpreting regulatory guidelines, liaising with health authorities, and maintaining regulatory compliance throughout the product lifecycle. You will work closely with R&D, quality assurance, and clinical teams to ensure that all regulatory requirements are met. The role also involves staying abreast of changes in the regulatory landscape and advising internal teams accordingly. Excellent written and verbal communication skills are essential, as is the ability to manage multiple projects simultaneously and meet strict deadlines. This is a remote-first role, offering flexibility and the opportunity to contribute to global drug approvals from your home office.
Key Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- Minimum 3-5 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulations (e.g., FDA, EMA).
- Proven experience in preparing and submitting regulatory dossiers (e.g., IND, NDA, MAA).
- Excellent understanding of drug development processes and clinical trial regulations.
- Strong analytical and problem-solving skills.
- Proficiency in regulatory information management systems.
- Ability to work independently, manage time effectively, and collaborate remotely.
We offer a competitive salary, benefits, and the opportunity to be part of a committed team driving innovation in pharmaceutical development. Join our client and contribute to bringing life-changing medicines to patients worldwide.