71 Regulatory Submissions jobs in Bahrain
Pharmaceutical Regulatory Affairs Specialist
Posted today
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Key Responsibilities:
- Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities.
- Maintain a thorough understanding of current and evolving national and international pharmaceutical regulations.
- Liaise with regulatory agencies to facilitate the review and approval process for pharmaceutical products.
- Provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing.
- Monitor regulatory intelligence and assess the impact of new regulations on company products and strategies.
- Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other relevant quality standards.
- Manage post-approval regulatory activities, such as annual reports and safety updates.
- Review and approve promotional materials and labeling to ensure regulatory compliance.
- Participate in regulatory audits and inspections.
- Maintain accurate and organized regulatory databases and filing systems.
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related life science field. A Master's degree is advantageous.
- Minimum of 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of regulatory submission processes and requirements in key markets.
- Familiarity with ICH guidelines and regional regulatory frameworks.
- Strong analytical, problem-solving, and critical thinking skills.
- Excellent written and verbal communication skills, with the ability to draft clear and concise regulatory documents.
- Meticulous attention to detail and a commitment to accuracy.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in regulatory information management systems is a plus.
- Must be able to work effectively within a hybrid model in **Shakhura, Northern, BH**.
Pharmaceutical Regulatory Affairs Specialist
Posted 5 days ago
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Pharmaceutical Regulatory Affairs Manager
Posted 20 days ago
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Remote Pharmaceutical Regulatory Affairs Specialist
Posted 2 days ago
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Job Description
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Interpret and apply national and international regulatory guidelines and regulations to ensure product compliance.
- Maintain regulatory databases and ensure timely updates for all product registrations and lifecycle management activities.
- Liaise with regulatory agencies (e.g., FDA, EMA) on behalf of the company to facilitate regulatory approvals and respond to queries.
- Provide regulatory guidance and support to internal teams, including R&D, clinical development, manufacturing, and quality assurance.
- Conduct regulatory intelligence activities to stay informed about changes in the regulatory landscape and assess their impact on company products.
- Develop and maintain standard operating procedures (SOPs) for regulatory affairs activities.
- Review and approve labeling, promotional materials, and advertising to ensure regulatory compliance.
- Manage post-approval regulatory activities, including annual reports and supplements.
- Participate in regulatory inspections and audits.
- Contribute to the strategic planning of regulatory submissions and product development programs.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or Pharm.D. is preferred.
- Minimum of 5 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory submission processes and requirements in key markets (e.g., US, Europe, Middle East).
- Experience with various dossier types (e.g., CTD format) and submission platforms.
- Strong understanding of pharmaceutical drug development, manufacturing, and quality assurance principles.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with strong attention to detail.
- Ability to interpret and apply complex regulatory documents.
- Proficiency in regulatory information management systems (RIMs) is a plus.
- Ability to work independently, manage multiple priorities, and meet strict deadlines in a remote environment.
- Strong collaboration and team-working skills.
This is an exceptional opportunity for a seasoned regulatory professional to contribute to groundbreaking pharmaceutical advancements from the comfort of their home.
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 2 days ago
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Key Responsibilities:
- Develop and implement regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers and documentation to health authorities worldwide.
- Liaise directly with regulatory agencies to address queries, facilitate approvals, and maintain positive relationships.
- Interpret and advise on the impact of evolving regulations on company products and processes.
- Ensure that all labeling, advertising, and promotional materials comply with relevant regulations.
- Conduct regulatory due diligence for potential acquisitions or partnerships.
- Manage post-approval regulatory activities, including variations, annual reports, and safety updates.
- Collaborate with R&D, Quality Assurance, Manufacturing, and Commercial teams to provide regulatory guidance and support.
- Maintain comprehensive and up-to-date regulatory intelligence.
- Oversee the regulatory compliance of clinical trial applications and amendments.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
- A minimum of 6 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., ICH guidelines, FDA, EMA, SFDA).
- Proven experience in preparing and submitting NDAs, MAAs, and variations.
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to analyze complex scientific and regulatory information.
- Strong negotiation and problem-solving skills.
- Experience working with cross-functional teams.
- Proficiency in regulatory information management systems.
- Must be able to work effectively in a team environment and independently.
This is an excellent opportunity for a dedicated professional to contribute to the success of life-saving medicines within a reputable organization.
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 3 days ago
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Remote Pharmaceutical Regulatory Affairs Specialist
Posted 4 days ago
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Senior Pharmaceutical Regulatory Affairs Specialist
Posted 7 days ago
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Key Responsibilities:
- Develop and implement global regulatory affairs strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, eCTD) to health authorities.
- Ensure compliance with global pharmaceutical regulations and guidelines (FDA, EMA, SFDA, etc.).
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Liaise with regulatory agencies, respond to queries, and manage inspections.
- Provide regulatory guidance and support to R&D, clinical operations, and manufacturing teams.
- Assess the regulatory impact of product changes and new developments.
- Monitor changes in regulatory landscape and advise the company accordingly.
- Conduct regulatory intelligence gathering and risk assessments.
- Maintain regulatory documentation and databases.
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of international pharmaceutical regulatory requirements and submission processes.
- Proven experience in preparing and submitting marketing authorization applications.
- Excellent scientific writing, communication, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple projects and meet strict deadlines.
- Experience with regulatory information management systems is a plus.
Remote Pharmaceutical Regulatory Affairs Specialist
Posted 9 days ago
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Key responsibilities include:
- Preparing, compiling, and submitting regulatory submissions (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
- Interpreting and advising on regulatory requirements and guidelines for drug development, manufacturing, and marketing.
- Communicating and negotiating with regulatory agencies to facilitate product approvals and address inquiries.
- Developing regulatory strategies for product development and lifecycle management.
- Reviewing and approving labeling, advertising, and promotional materials to ensure regulatory compliance.
- Maintaining regulatory documentation and databases, ensuring accuracy and completeness.
- Monitoring changes in the regulatory environment and assessing their impact on company products and strategies.
- Providing regulatory training and support to internal teams.
- Collaborating with R&D, manufacturing, and quality assurance departments to ensure compliance throughout the product lifecycle.
- Participating in regulatory inspections and audits.
Senior Pharmaceutical Regulatory Affairs Specialist
Posted 12 days ago
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