156 Regulatory Affairs Specialists jobs in Bahrain
Regulatory Affairs Specialist
5121 Northern, Northern
BHD70000 Annually
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Our client is seeking a meticulous and experienced Regulatory Affairs Specialist to join their team in the pharmaceutical sector. This vital role involves ensuring that all company products comply with relevant national and international regulations governing the pharmaceutical industry. You will be responsible for preparing, submitting, and managing regulatory documentation, liaising with health authorities, and staying informed about evolving regulatory landscapes. The ideal candidate will have a strong understanding of drug development processes and a proven ability to navigate complex regulatory requirements.
Responsibilities:
Location: Shakhura, Northern, BH
Responsibilities:
- Prepare and submit regulatory dossiers for new drug applications (NDAs), variations, and renewals to health authorities.
- Ensure all regulatory documentation is accurate, complete, and compliant with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
- Maintain a deep understanding of global pharmaceutical regulations and guidelines.
- Liaise with regulatory agencies (e.g., FDA, EMA, SFDA) on behalf of the company.
- Review and approve promotional materials, labeling, and advertising for regulatory compliance.
- Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
- Monitor changes in regulations and assess their impact on company products and processes.
- Manage post-market surveillance activities and pharmacovigilance reporting.
- Conduct internal audits to ensure compliance with regulatory standards.
- Develop and implement regulatory strategies for product development and lifecycle management.
- Review and approve batch records and quality control data for regulatory submissions.
- Participate in regulatory inspections and respond to queries from health authorities.
- Collaborate with external partners and contract research organizations (CROs) on regulatory matters.
- Maintain regulatory databases and filing systems.
- Contribute to the development of company policies and procedures related to regulatory affairs.
- Assess the regulatory status of products in different markets.
- Support the preparation of responses to deficiency letters from regulatory agencies.
- Ensure compliance with serialization and track-and-trace requirements.
- Provide training to staff on regulatory compliance topics.
- Build and maintain strong relationships with key regulatory stakeholders.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Master's degree is a plus.
- Minimum of 4-6 years of experience in regulatory affairs within the pharmaceutical industry.
- Proven experience in preparing and submitting regulatory dossiers for different types of applications.
- In-depth knowledge of global pharmaceutical regulations, ICH guidelines, and regional requirements.
- Excellent written and verbal communication skills, with strong attention to detail.
- Proficiency in regulatory information management (RIM) systems.
- Strong analytical and problem-solving abilities.
- Ability to work independently and collaboratively in a team environment.
- Proficiency in English and strong technical writing skills.
- Familiarity with drug development lifecycle and manufacturing processes.
- Experience with regulatory submissions in the Middle East region is advantageous.
- Ability to manage multiple projects and prioritize tasks effectively.
- High ethical standards and commitment to compliance.
- Adaptability to evolving regulatory frameworks.
- Experience interacting with regulatory agencies.
Location: Shakhura, Northern, BH
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0
Regulatory Affairs Specialist
06250 Seef, Capital
BHD70000 Annually
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Our client, a prominent firm in the biotechnology sector, is seeking a diligent and experienced Regulatory Affairs Specialist to join their esteemed legal and compliance team in **Jidhafs, Capital, BH**. This vital role ensures that the company's products and operations adhere to all relevant national and international regulatory standards. The ideal candidate will possess a thorough understanding of regulatory frameworks, submission processes, and compliance requirements within the biotechnology industry. Key responsibilities include preparing, reviewing, and submitting regulatory documentation to health authorities for product approvals and ongoing compliance. You will monitor changes in regulatory legislation and guidelines, assessing their impact on the company's products and strategies. The successful applicant will liaise with regulatory agencies, manage post-market surveillance activities, and ensure that product labeling and marketing materials are compliant. You will also provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing. A Bachelor's degree in a life science, chemistry, pharmacy, or a related field is required, along with at least 4 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry. Knowledge of GMP, GCP, and GLP principles is essential. Excellent analytical, written, and verbal communication skills are crucial for successful interactions with regulatory bodies and internal stakeholders. Experience with dossier preparation and submission software is a significant advantage. This is an excellent opportunity to contribute to the compliance and market access of innovative biotechnology products in **Jidhafs, Capital, BH**.
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1
Senior Regulatory Affairs Specialist
33334 Askar, Southern
BHD100000 Annually
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Our pharmaceutical client is seeking a highly motivated Senior Regulatory Affairs Specialist to join their dedicated team. This fully remote position will play a critical role in ensuring compliance with global regulatory requirements for drug development and marketing. You will be responsible for preparing and submitting regulatory documentation, interacting with health authorities, and providing strategic regulatory guidance throughout the product lifecycle. Your expertise in regulatory submissions and knowledge of pharmaceutical regulations are essential.
Key Responsibilities:
Qualifications:
This is an exciting opportunity for a seasoned regulatory professional to contribute to bringing life-saving medications to market, all within a flexible, fully remote work setting.
Key Responsibilities:
- Prepare, review, and submit regulatory filings (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Develop and implement regulatory strategies for product development and lifecycle management.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Serve as a primary point of contact for regulatory agencies.
- Interpret and advise on regulatory guidelines and policies.
- Review and approve promotional materials and labeling for regulatory compliance.
- Conduct regulatory due diligence for potential partnerships and acquisitions.
- Maintain regulatory databases and documentation systems.
- Collaborate with cross-functional teams, including R&D, clinical affairs, quality assurance, and commercial.
- Stay updated on emerging regulatory trends and guidelines.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. Master's degree or Pharm.D. preferred.
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- In-depth knowledge of global regulatory submission processes and requirements (FDA, EMA, etc.).
- Experience with preparing and submitting electronic regulatory dossiers (eCTD).
- Strong understanding of drug development processes and lifecycle management.
- Excellent analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with strong attention to detail.
- Ability to work independently and manage multiple projects in a remote environment.
This is an exciting opportunity for a seasoned regulatory professional to contribute to bringing life-saving medications to market, all within a flexible, fully remote work setting.
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2
Senior Regulatory Affairs Specialist
20744 Hamad Town, Northern
BHD100000 Annually
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Our client is seeking a highly qualified Senior Regulatory Affairs Specialist to join their team. This role offers a hybrid work arrangement, blending remote work with necessary on-site responsibilities for critical meetings and operational tasks. You will be responsible for ensuring compliance with all relevant regulations and guidelines governing our client's products and operations. This includes preparing and submitting regulatory filings, responding to inquiries from regulatory agencies, and staying abreast of changes in the regulatory landscape. The Senior Regulatory Affairs Specialist will provide strategic guidance on regulatory matters, conduct regulatory assessments for new products and processes, and develop regulatory strategies to support business objectives. A deep understanding of the specific regulatory frameworks relevant to the industry is essential. You will collaborate closely with R&D, marketing, and legal departments to ensure alignment on regulatory requirements. The ideal candidate will have a Bachelor's or Master's degree in a scientific, technical, or legal field, with significant experience in regulatory affairs. Excellent analytical, written, and verbal communication skills are paramount, as is the ability to interpret complex regulations and apply them to practical business scenarios. This role requires meticulous attention to detail, strong project management skills, and the ability to work both independently and collaboratively in a hybrid setting. Your expertise will be crucial in navigating the regulatory environment and ensuring market access for our client's offerings.
Responsibilities:
Responsibilities:
- Ensure compliance with all applicable regulations.
- Prepare and submit regulatory filings and applications.
- Respond to inquiries from regulatory authorities.
- Develop and implement regulatory strategies.
- Conduct regulatory assessments for new products and processes.
- Monitor and interpret regulatory changes.
- Collaborate with internal departments on regulatory matters.
- Maintain regulatory documentation and databases.
- Provide regulatory training to staff.
- Bachelor's or Master's degree in a relevant scientific, technical, or legal field.
- 5+ years of experience in regulatory affairs.
- In-depth knowledge of relevant regulatory frameworks.
- Experience with regulatory submissions and filings.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication abilities.
- Proficiency in regulatory information management systems.
- Ability to interpret and apply complex regulations.
- Strong project management and organizational skills.
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3
Lead Regulatory Affairs Specialist
98765 Bilad Al Qadeem, Capital
BHD90000 Annually
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Our client is a distinguished global leader in the (Specify Industry, e.g., Pharmaceutical or Medical Device) sector, seeking a seasoned Lead Regulatory Affairs Specialist to bolster their compliance and product approval endeavors. This is a critical fully remote role, enabling you to contribute significantly to our operations from your chosen location. You will be tasked with overseeing and managing all aspects of regulatory affairs, ensuring that our products meet the stringent requirements of various international regulatory bodies and agencies. Your responsibilities will encompass preparing and submitting regulatory dossiers, managing post-market surveillance, and staying abreast of evolving regulatory landscapes and guidelines. You will collaborate closely with R&D, Quality Assurance, and Marketing departments to ensure regulatory compliance throughout the product lifecycle. Key activities include developing regulatory strategies, conducting regulatory impact assessments, and providing guidance on compliance matters. The ideal candidate will possess a Bachelor’s degree in a science-related field (e.g., Biology, Chemistry, Pharmacy) or a related discipline, coupled with a minimum of 8 years of hands-on experience in regulatory affairs, with a strong emphasis on regulatory submissions and strategy. Proven expertise in navigating regulatory pathways for (Specific product type) is highly desirable. Exceptional attention to detail, strong analytical and problem-solving skills, and outstanding written and verbal communication abilities are essential. This is a remote-first position, demanding a high degree of self-discipline, organization, and the ability to work autonomously while maintaining seamless collaboration with global teams through digital platforms. You will play a pivotal role in ensuring market access for our innovative products and maintaining our company's reputation for quality and compliance. A Master's degree or specialized regulatory affairs certification would be an advantage. Our client is committed to fostering a culture of excellence and provides an environment where regulatory professionals can truly make a difference.
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4
Regulatory Affairs Specialist (Legal)
BH-008 Al Hidd
BHD90000 Annually
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Posted 3 days ago
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Our client is seeking a meticulous and experienced Regulatory Affairs Specialist to join their legal and compliance team. This is a fully remote role, enabling you to contribute your expertise without geographical constraints. You will be instrumental in ensuring the company's adherence to all relevant local and international regulations across its various operations. Key responsibilities include monitoring regulatory changes, assessing their impact, and developing strategies to ensure compliance. You will be responsible for preparing and submitting regulatory filings, maintaining regulatory documentation, and liaising with regulatory authorities. This role requires a thorough understanding of legal frameworks, compliance procedures, and industry-specific regulations. The ideal candidate will possess strong research skills, excellent attention to detail, and the ability to interpret complex legal and regulatory texts. Proficiency in regulatory databases and documentation management systems is essential. You will collaborate closely with legal, product development, and business teams to navigate regulatory landscapes and mitigate compliance risks. Exceptional communication and organizational skills are vital for success in this remote position. Our client values individuals who are proactive, detail-oriented, and dedicated to upholding the highest standards of regulatory compliance, offering a flexible and supportive work environment.
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5
Senior Regulatory Affairs Specialist
1011 Tubli, Central
BHD135000 Annually
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Posted 15 days ago
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Our client, a prominent international law firm with a strong practice in the Middle East, is seeking an experienced Senior Regulatory Affairs Specialist to join their esteemed legal team in **Janabiyah, Northern, BH**. This crucial role requires a deep understanding of the regulatory landscape in Bahrain and the wider GCC region, focusing on compliance and legal advisory services for diverse industries. The Senior Regulatory Affairs Specialist will be responsible for advising clients on navigating complex regulatory frameworks, obtaining necessary licenses and permits, and ensuring ongoing compliance with local laws and international standards. You will conduct thorough regulatory research, analyze legislative changes, and provide strategic guidance to clients to mitigate legal and operational risks. This position demands exceptional analytical skills, meticulous attention to detail, and strong communication abilities to effectively liaise with government agencies, regulatory bodies, and clients. The ideal candidate will possess a comprehensive knowledge of corporate law, commercial regulations, and industry-specific compliance requirements.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Provide expert advice on regulatory compliance and legal requirements in Bahrain and the GCC.
- Assist clients in obtaining licenses, permits, and approvals from relevant authorities.
- Monitor regulatory changes and assess their impact on client businesses.
- Develop and implement compliance programs and policies for clients.
- Conduct regulatory due diligence and risk assessments.
- Prepare and review regulatory submissions and documentation.
- Liaise effectively with government agencies and regulatory bodies.
- Advise on corporate governance and corporate secretarial matters.
- Support legal teams in complex transactions and cross-border dealings.
- Ensure clients adhere to industry-specific regulations and best practices.
Qualifications:
- Law degree (LLB or JD) or a relevant degree in Public Administration, Business, or Economics.
- Minimum of 7 years of experience in regulatory affairs, compliance, legal advisory, or corporate governance.
- In-depth knowledge of Bahraini and GCC regulatory environments and business laws.
- Experience in liaising with government authorities and regulatory bodies.
- Strong analytical, research, and problem-solving skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple projects and meet demanding deadlines.
- Proficiency in legal research databases and compliance software.
- Understanding of corporate law and company formation procedures.
- Fluency in English is essential; Arabic language proficiency is highly advantageous.
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6
Senior Pharmaceutical Regulatory Affairs Specialist
2031 Northern, Northern
BHD115000 Annually
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Our client, a leading pharmaceutical innovator, is seeking a highly competent Senior Pharmaceutical Regulatory Affairs Specialist to join their expanding, fully remote team. This pivotal role involves ensuring compliance with global regulatory requirements throughout the drug development lifecycle, from pre-clinical studies to post-market surveillance. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance to internal teams.
Key Responsibilities:
Key Responsibilities:
- Develop and implement global regulatory strategies for product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, CTAs) to health authorities worldwide.
- Serve as the primary point of contact with regulatory agencies, responding to queries and facilitating communication.
- Monitor and interpret evolving regulatory guidelines and advise internal teams on their impact.
- Conduct regulatory intelligence activities to identify emerging trends and opportunities.
- Provide regulatory guidance and support to R&D, clinical operations, manufacturing, and commercial teams.
- Ensure that all company activities and products comply with applicable pharmaceutical regulations and guidelines.
- Manage the regulatory submission process, including timelines and resource allocation.
- Review and approve labeling, promotional materials, and other regulated documents.
- Participate in regulatory strategy meetings and contribute to decision-making.
- Maintain regulatory documentation and databases.
- Support regulatory aspects of due diligence for business development opportunities.
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7
Senior Pharmaceutical Regulatory Affairs Specialist
21503 Busaiteen, Muharraq
BHD72000 Annually
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Our client is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their team in **Busaiteen, Muharraq, BH**. This vital role is responsible for ensuring compliance with all relevant pharmaceutical regulations and guidelines for product registration and lifecycle management. The ideal candidate will possess in-depth knowledge of regulatory submission processes, a strong understanding of global pharmaceutical markets, and meticulous attention to detail. You will manage regulatory submissions, liaise with health authorities, and advise internal teams on regulatory requirements.
Key responsibilities include:
The ideal candidate will hold a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or equivalent advanced degree is a plus. A minimum of 5 years of experience in pharmaceutical regulatory affairs is required. Strong knowledge of ICH guidelines and experience with eCTD submissions are essential. Familiarity with different global regulatory agencies is highly desirable. Excellent written and verbal communication skills, as well as strong analytical and problem-solving abilities, are necessary. This is an on-site position at our **Busaiteen, Muharraq, BH** facility.
Key responsibilities include:
- Preparing, submitting, and managing regulatory dossiers for new drug applications (NDAs) and variations.
- Ensuring all regulatory submissions comply with local and international requirements (e.g., FDA, EMA, SFDA).
- Liaising with health authorities and responding to queries during the review process.
- Monitoring regulatory changes and providing updates and guidance to internal stakeholders.
- Developing and implementing regulatory strategies for product lifecycle management.
- Reviewing labeling, promotional materials, and marketing claims for regulatory compliance.
- Participating in regulatory inspections and audits.
- Collaborating with R&D, Quality Assurance, and Commercial teams to ensure regulatory alignment.
- Maintaining regulatory databases and records.
- Providing training on regulatory compliance to relevant personnel.
The ideal candidate will hold a Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field. A Master's degree or equivalent advanced degree is a plus. A minimum of 5 years of experience in pharmaceutical regulatory affairs is required. Strong knowledge of ICH guidelines and experience with eCTD submissions are essential. Familiarity with different global regulatory agencies is highly desirable. Excellent written and verbal communication skills, as well as strong analytical and problem-solving abilities, are necessary. This is an on-site position at our **Busaiteen, Muharraq, BH** facility.
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8
Senior Regulatory Affairs Specialist - Pharmaceutical
100 Manama, Capital
BHD85000 Annually
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Our client, a leading pharmaceutical company renowned for its commitment to innovation and patient well-being, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their dedicated team in Manama, Capital, BH . This critical role involves ensuring compliance with all relevant national and international pharmaceutical regulations, facilitating the successful registration and lifecycle management of medicinal products. The ideal candidate will possess a profound understanding of the pharmaceutical industry's regulatory landscape and a proven ability to navigate complex submission processes.
As a Senior Regulatory Affairs Specialist, you will be responsible for preparing, reviewing, and submitting regulatory dossiers for new drug applications, variations, and renewals. You will liaise with health authorities, manage regulatory timelines, and provide expert guidance on regulatory strategies to internal stakeholders, including R&D, marketing, and manufacturing departments. Key responsibilities include staying abreast of evolving regulatory requirements, conducting regulatory intelligence assessments, and ensuring that all product labeling and promotional materials comply with applicable laws and guidelines. This position requires meticulous attention to detail, strong project management skills, and the ability to manage multiple priorities effectively. A collaborative spirit and excellent communication skills are essential for success in this role, as you will be working with cross-functional teams and external partners.
Key Responsibilities:
As a Senior Regulatory Affairs Specialist, you will be responsible for preparing, reviewing, and submitting regulatory dossiers for new drug applications, variations, and renewals. You will liaise with health authorities, manage regulatory timelines, and provide expert guidance on regulatory strategies to internal stakeholders, including R&D, marketing, and manufacturing departments. Key responsibilities include staying abreast of evolving regulatory requirements, conducting regulatory intelligence assessments, and ensuring that all product labeling and promotional materials comply with applicable laws and guidelines. This position requires meticulous attention to detail, strong project management skills, and the ability to manage multiple priorities effectively. A collaborative spirit and excellent communication skills are essential for success in this role, as you will be working with cross-functional teams and external partners.
Key Responsibilities:
- Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations, renewals) to health authorities.
- Develop and implement regulatory strategies to support product development and commercialization.
- Act as the primary point of contact for regulatory agencies.
- Interpret and communicate regulatory guidelines and requirements to internal teams.
- Ensure compliance of product labeling, packaging, and promotional materials with regulatory standards.
- Conduct regulatory intelligence gathering and analysis to identify potential impacts on the business.
- Manage the lifecycle of approved products, including post-approval changes and reporting.
- Provide regulatory input and support for clinical trial applications.
- Contribute to the development and maintenance of regulatory quality systems.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
- Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical industry.
- In-depth knowledge of pharmaceutical regulatory requirements and guidelines (e.g., ICH, FDA, EMA, SFDA).
- Proven experience in preparing and submitting marketing authorization applications.
- Excellent written and verbal communication skills, with strong attention to detail.
- Strong project management and organizational skills.
- Ability to work independently and collaboratively in a team environment.
- Proficiency in regulatory information management systems is a plus.
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