48 Regulatory Submissions jobs in Bahrain

Pharmaceutical Regulatory Affairs Manager

80501 Isa Town, Northern BHD100000 Annually WhatJobs

Posted 1 day ago

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full-time
Our client, a dynamic pharmaceutical company, is seeking a seasoned Pharmaceutical Regulatory Affairs Manager to lead and manage all aspects of regulatory submissions and compliance. This is a fully remote position, offering an excellent opportunity to contribute to the launch and lifecycle management of innovative pharmaceutical products. You will be responsible for developing regulatory strategies, preparing and submitting high-quality dossiers to global health authorities (e.g., FDA, EMA, MHRA), and ensuring adherence to all relevant regulations and guidelines. Key duties include interpreting regulatory requirements, advising project teams on regulatory strategy, and managing post-approval regulatory activities. The Pharmaceutical Regulatory Affairs Manager will also be involved in regulatory intelligence gathering, staying current with evolving global regulations, and assessing their impact on the company's product portfolio. Building and maintaining strong relationships with regulatory agencies will be crucial for success. The ideal candidate will possess a Bachelor's or Master's degree in a life science or related field, with substantial experience in pharmaceutical regulatory affairs. Demonstrated success in managing regulatory submissions for new drug applications (NDAs) or marketing authorization applications (MAAs) is essential. Strong knowledge of ICH guidelines and regional regulatory requirements is a must. Excellent written and verbal communication skills, meticulous attention to detail, and strong project management abilities are required. This role offers significant autonomy and the chance to work on a variety of exciting projects, contributing directly to bringing life-changing medicines to patients worldwide. Join our client and be a key player in global drug development.
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Pharmaceutical Regulatory Affairs Specialist

703 Hamad Town, Northern BHD70000 Annually WhatJobs

Posted 12 days ago

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full-time
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:
  • 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 .
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Pharmaceutical Regulatory Affairs Specialist

400 Seef, Capital BHD7000 Monthly WhatJobs

Posted 14 days ago

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full-time
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:
  • 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 is a critical role for an individual passionate about ensuring the safety and efficacy of pharmaceutical products reaching the market. You will be a key contributor to our company's success in bringing innovative treatments to patients.
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Senior Pharmaceutical Regulatory Affairs Specialist

1101 Al Malikiyah, Northern BHD72000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a reputable pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist. This role is vital for ensuring compliance with all relevant national and international regulations governing pharmaceutical products. The position offers a hybrid work model, combining remote flexibility with essential on-site collaboration at their facility in **Hidd, Muharraq, BH**.

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**.
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Remote Pharmaceutical Regulatory Affairs Specialist

217 Al Malikiyah, Northern BHD75000 Annually WhatJobs

Posted 3 days ago

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Job Description

full-time
Our client, a dynamic and innovative pharmaceutical company, is seeking a highly skilled and detail-oriented Remote Pharmaceutical Regulatory Affairs Specialist to join their global team. This is a fully remote opportunity, allowing you to contribute to our mission of bringing life-saving medications to market from your home office. You will play a crucial role in ensuring compliance with regulatory requirements for drug development and marketing. This involves preparing, submitting, and maintaining regulatory documentation for new drug applications, variations, and post-approval changes across various international markets. The ideal candidate will have a deep understanding of pharmaceutical regulations and a proven ability to navigate complex regulatory landscapes. You will collaborate closely with cross-functional teams, including R&D, manufacturing, and quality assurance, to ensure regulatory strategies are aligned with business objectives. This role is essential for facilitating the timely approval and accessibility of our client's pharmaceutical products. Responsibilities include:
  • 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.
Qualifications:
  • 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.
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Remote Pharmaceutical Regulatory Affairs Specialist

610 Manama, Capital BHD90000 Annually WhatJobs

Posted 4 days ago

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Job Description

full-time
Our client, a well-established pharmaceutical company, is seeking a highly knowledgeable and meticulous Remote Pharmaceutical Regulatory Affairs Specialist. This position is fully remote, offering the opportunity to contribute to critical compliance and submission processes from anywhere. You will be responsible for ensuring that all pharmaceutical products meet the stringent regulatory requirements of relevant health authorities worldwide. This includes preparing, reviewing, and submitting regulatory dossiers (e.g., INDs, NDAs, MAAs), and responding to queries from regulatory agencies. Key responsibilities involve staying abreast of evolving global regulatory landscapes, providing regulatory guidance to internal teams, and assessing the regulatory implications of product development and lifecycle management. You will play a crucial role in managing post-approval regulatory activities, including variations, renewals, and annual reports. The ideal candidate will possess a strong understanding of pharmaceutical development, manufacturing processes, and quality systems. Exceptional analytical and critical thinking skills are essential, along with meticulous attention to detail and the ability to manage complex documentation. Excellent written and verbal communication skills are required for interacting with regulatory bodies and internal stakeholders. Proficiency in regulatory information management (RIM) systems is highly desirable. We are looking for a proactive, self-motivated individual who can work independently, manage multiple projects simultaneously, and thrive in a dynamic remote work environment. A solid background in pharmaceutical sciences or a related field, coupled with extensive experience in regulatory affairs, is a must. If you are a dedicated professional seeking a challenging remote role where you can make a significant impact on bringing life-saving medicines to market, we encourage you to apply.
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Remote Pharmaceutical Regulatory Affairs Specialist

102 Hamad Town, Northern BHD85000 Annually WhatJobs

Posted 7 days ago

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full-time
Our client is seeking a meticulous and experienced Remote Pharmaceutical Regulatory Affairs Specialist to ensure our products meet all necessary regulatory requirements for market approval and ongoing compliance. This position is fully remote, offering flexibility while demanding a high level of expertise and dedication. You will be responsible for preparing, reviewing, and submitting regulatory documentation, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Investigational New Drug (IND) applications, and post-approval supplements. Your role will involve staying abreast of evolving global regulatory landscapes, including those set by the FDA, EMA, and other health authorities. You will collaborate closely with R&D, clinical, manufacturing, and quality assurance teams to gather necessary data and ensure that submissions are accurate, complete, and timely. Key responsibilities include interpreting regulatory guidelines, advising on regulatory strategies, and managing regulatory agency interactions. The ideal candidate will possess a strong understanding of pharmaceutical development processes, clinical trials, and manufacturing operations. Exceptional written and verbal communication skills, strong attention to detail, and the ability to manage multiple complex projects simultaneously are essential. This is an excellent opportunity to contribute to bringing life-saving medications to patients worldwide from a remote setting.

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.
Qualifications:
  • 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

12345 Al Muharraq BHD75000 Annually WhatJobs

Posted 9 days ago

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Job Description

full-time
Our client is seeking a highly experienced and detail-oriented Remote Pharmaceutical Regulatory Affairs Specialist to join their dynamic team. This is a fully remote position, offering an excellent opportunity for a regulatory expert to contribute to the successful registration and compliance of pharmaceutical products globally. The ideal candidate will possess a deep understanding of international regulatory requirements, submission processes, and quality guidelines. This role demands strong analytical skills, excellent written and verbal communication, and the ability to manage multiple complex projects concurrently.

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.
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Senior Pharmaceutical Regulatory Affairs Manager

2015 Al Seef BHD105000 Annually WhatJobs

Posted 10 days ago

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full-time
Our client, a dynamic and growing pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Manager. This fully remote role allows you to leverage your extensive knowledge of global regulatory landscapes from anywhere. You will be responsible for developing and executing regulatory strategies for product development, submission, and lifecycle management. This includes ensuring compliance with all relevant health authority regulations, preparing and submitting regulatory dossiers, and serving as a key liaison with regulatory agencies worldwide. The ideal candidate possesses a deep understanding of the pharmaceutical industry, excellent analytical and communication skills, and a proven ability to navigate complex regulatory environments.

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**.
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Remote Pharmaceutical Regulatory Affairs Specialist

88320 Ghuraifa, Capital BHD75000 Annually WhatJobs

Posted 15 days ago

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Job Description

full-time
Our client, a rapidly expanding pharmaceutical company, is seeking a highly motivated and detail-oriented Remote Pharmaceutical Regulatory Affairs Specialist. This fully remote position is critical for ensuring that our client's products comply with all relevant national and international regulations. You will be responsible for preparing, reviewing, and submitting regulatory documentation for drug development, clinical trials, and marketing authorizations. The ideal candidate will possess a strong understanding of pharmaceutical regulations and a proven ability to navigate complex regulatory pathways.

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.
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