224 Certified Compliance Ethics Professional jobs in Bahrain
Regulatory Affairs Specialist
Posted 8 days ago
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Job Description
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.
Regulatory Affairs Specialist
Posted 15 days ago
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Job Description
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.
Pharmaceutical Regulatory Affairs Manager
Posted 1 day ago
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Senior Regulatory Affairs Specialist
Posted 3 days ago
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Job Description
- 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.
Senior Regulatory Affairs Specialist
Posted 8 days ago
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Senior Regulatory Affairs Counsel
Posted 8 days ago
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Job Description
- Providing expert legal advice and strategic guidance on a wide range of regulatory compliance issues.
- Interpreting and applying complex statutes, regulations, and case law relevant to client operations.
- Developing, implementing, and maintaining robust compliance programs and policies.
- Conducting thorough legal research and due diligence on regulatory matters.
- Drafting and reviewing legal documents, including agreements, opinions, and filings.
- Representing clients in interactions with regulatory agencies and authorities.
- Assisting clients with license applications, permits, and regulatory approvals.
- Advising on risk mitigation strategies related to regulatory non-compliance.
- Staying current with legislative changes and emerging regulatory trends impacting client industries.
- Collaborating with internal teams and external counsel to provide comprehensive legal solutions.
- Training and advising client personnel on regulatory compliance best practices.
- Managing a portfolio of regulatory matters with a focus on efficiency and client satisfaction.
Qualifications: Juris Doctor (JD) or equivalent law degree from an accredited institution. Admission to practice law in a relevant jurisdiction. A minimum of 8 years of substantial experience in regulatory affairs law, with a strong emphasis on compliance, policy development, and transactional matters. Demonstrated expertise in specific regulated industries (e.g., finance, healthcare, technology, energy). Exceptional analytical, critical thinking, and problem-solving abilities. Outstanding written and verbal communication skills, with the ability to articulate complex legal concepts clearly. Proven ability to manage complex legal projects and meet demanding deadlines. Experience in conducting regulatory due diligence and advising on cross-border compliance. A proactive and client-focused approach, with the ability to build and maintain strong client relationships. This fully remote position offers the flexibility to work from anywhere while contributing significantly to high-profile legal cases and client success, supporting operations that may be linked to the region of **Isa Town, Southern, BH**.
Pharmaceutical Regulatory Affairs Specialist
Posted 11 days ago
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Job Description
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
Posted 13 days ago
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Job Description
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 Regulatory Affairs Counsel
Posted 14 days ago
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Job Description
Key Responsibilities:
- Monitor, interpret, and advise on current and emerging regulatory requirements and legislation.
- Develop and implement robust compliance programs and policies.
- Conduct regulatory risk assessments and identify areas for improvement.
- Prepare and submit regulatory filings and applications as required.
- Liaise with regulatory agencies and authorities on behalf of the company.
- Provide expert legal counsel on regulatory matters to senior management and relevant departments.
- Oversee the company's compliance training programs.
- Investigate potential compliance breaches and recommend corrective actions.
- Stay up-to-date with industry best practices in regulatory affairs and compliance.
- Collaborate with internal teams to ensure product and service compliance.
- Manage external counsel in relation to regulatory matters.
- Draft and review legal documents related to regulatory compliance.
Qualifications:
- Juris Doctor (JD) or equivalent law degree from a reputable institution.
- Admission to practice law in a relevant jurisdiction.
- A minimum of 7 years of experience in regulatory affairs, compliance, or corporate law, with a specialization in a relevant industry.
- Extensive knowledge of relevant local and international regulations.
- Proven experience in developing and implementing compliance programs.
- Strong analytical, research, and problem-solving skills.
- Excellent written and verbal communication skills, with the ability to articulate complex legal concepts clearly.
- Demonstrated ability to work independently and manage multiple priorities in a remote setting.
- Strong negotiation and influencing skills.
- Experience in building and maintaining relationships with regulatory bodies.
- High level of integrity and professional ethics.
Senior Regulatory Affairs Specialist
Posted 14 days ago
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Job Description
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.