25 Regulatory Submissions jobs in Bahrain
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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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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1
Senior Pharmaceutical Regulatory Affairs Manager
2204 Hamad Town, Northern
BHD9000 month
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Our client, a prominent pharmaceutical company, is seeking a highly experienced and meticulous Senior Pharmaceutical Regulatory Affairs Manager to lead their regulatory compliance efforts in Hamad Town, Northern, BH . This pivotal role is responsible for ensuring that all pharmaceutical products meet stringent local and international regulatory standards throughout their lifecycle. The ideal candidate will possess comprehensive knowledge of pharmaceutical regulations, a strong track record in dossier preparation and submission, and excellent leadership skills to guide the regulatory affairs team.
Key Responsibilities:
Key Responsibilities:
- Develop and implement regulatory strategies for the submission and approval of new pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., CTD format) to health authorities in accordance with guidelines.
- Ensure ongoing compliance with all relevant pharmaceutical laws, regulations, and guidelines applicable in target markets.
- Manage post-approval regulatory activities, including variations, renewals, and annual reports.
- Liaise with health authorities and regulatory agencies on behalf of the company, addressing queries and facilitating approvals.
- Monitor changes in the regulatory landscape and assess their impact on the company’s products and operations.
- Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, quality assurance, and marketing.
- Oversee the labeling and promotional material review process to ensure compliance with regulatory requirements.
- Manage the regulatory affairs team, providing mentorship, training, and performance management.
- Participate in regulatory audits and inspections.
- Develop and maintain regulatory intelligence databases and knowledge repositories.
- Contribute to the strategic planning and business development initiatives by providing regulatory insights.
- Ensure accurate and timely regulatory documentation is maintained.
- Represent the company in industry forums and regulatory meetings as needed.
- A Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. A Master’s degree or Ph.D. is a strong asset.
- Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs, with a significant portion in a management or senior specialist role.
- In-depth knowledge of global pharmaceutical regulatory requirements (e.g., FDA, EMA, SFDA, GCC-DR) and submission processes.
- Proven experience in preparing and submitting successful marketing authorization applications.
- Excellent understanding of drug development, manufacturing, and quality assurance principles.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with meticulous attention to detail.
- Proven leadership and team management capabilities.
- Proficiency in regulatory information management systems and software.
- Fluency in English; Arabic language skills are beneficial.
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2
Senior Pharmaceutical Regulatory Affairs Specialist
777 Bilad Al Qadeem, Capital
BHD4200 Annually
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Our client, a leading innovator in the pharmaceutical sector, is seeking a highly knowledgeable and experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their team in Salmabad, Northern, BH . This role is integral to ensuring that all pharmaceutical products and processes comply with the stringent regulations set forth by health authorities. The ideal candidate will possess a deep understanding of global regulatory landscapes, submission processes, and lifecycle management for pharmaceutical products. You will play a vital role in navigating complex regulatory pathways and ensuring timely market access for our client's innovative medicines.
Responsibilities:
Qualifications:
Responsibilities:
- Develop and execute regulatory strategies for product registration and lifecycle management in target markets.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, MAA) to health authorities.
- Liaise directly with regulatory agencies to address inquiries and facilitate approvals.
- Ensure ongoing compliance with all applicable regulations, guidelines, and company policies.
- Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
- Provide regulatory guidance and support to cross-functional teams, including R&D, Manufacturing, and Marketing.
- Manage post-approval regulatory activities, such as variations, renewals, and labeling updates.
- Conduct regulatory intelligence activities to identify new opportunities and potential risks.
- Maintain and organize regulatory documentation and databases.
- Contribute to the development of company regulatory policies and procedures.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory requirements in key markets (e.g., US FDA, EMA, MENA authorities).
- Proven experience in preparing and submitting regulatory dossiers.
- Strong understanding of pharmaceutical development, manufacturing, and quality systems.
- Excellent analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, with a strong command of scientific and regulatory terminology.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in regulatory information management systems.
- Attention to detail and a commitment to accuracy.
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Senior Pharmaceutical Regulatory Affairs Specialist - Remote
2205 Seef, Capital
BHD105000 Annually
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A dynamic international pharmaceutical company is seeking a Senior Pharmaceutical Regulatory Affairs Specialist for a fully remote position. This role is critical in ensuring that our products comply with all relevant national and international pharmaceutical regulations, facilitating the timely approval and market access of our innovative therapies. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes.
Key responsibilities include developing regulatory strategies, interpreting and applying complex regulatory guidelines, managing the lifecycle of regulatory submissions (INDs, NDAs, MAAs, etc.), and ensuring compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GVP). You will also review and approve labeling and promotional materials to ensure regulatory compliance. Collaboration with internal teams, including R&D, clinical operations, and manufacturing, will be essential.
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field, with a minimum of 7 years of experience in pharmaceutical regulatory affairs. Proven experience in preparing and managing regulatory submissions across key markets (e.g., US, EU, GCC) is required. Strong knowledge of regulatory submission software and databases is necessary. Excellent analytical, written, and verbal communication skills are paramount, as is the ability to work independently and manage multiple projects efficiently. A deep understanding of the drug development process and a proactive approach to regulatory challenges are essential for success in this remote-first role.
Key responsibilities include developing regulatory strategies, interpreting and applying complex regulatory guidelines, managing the lifecycle of regulatory submissions (INDs, NDAs, MAAs, etc.), and ensuring compliance with Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Pharmacovigilance Practice (GVP). You will also review and approve labeling and promotional materials to ensure regulatory compliance. Collaboration with internal teams, including R&D, clinical operations, and manufacturing, will be essential.
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field, with a minimum of 7 years of experience in pharmaceutical regulatory affairs. Proven experience in preparing and managing regulatory submissions across key markets (e.g., US, EU, GCC) is required. Strong knowledge of regulatory submission software and databases is necessary. Excellent analytical, written, and verbal communication skills are paramount, as is the ability to work independently and manage multiple projects efficiently. A deep understanding of the drug development process and a proactive approach to regulatory challenges are essential for success in this remote-first role.
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4
Senior Corporate Counsel, Regulatory Compliance
11701 Seef, Capital
BHD150000 Annually
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Our client is seeking a highly motivated and experienced Senior Corporate Counsel specializing in Regulatory Compliance to join their esteemed legal team. This is a fully remote, international position, offering flexibility and the opportunity to work with a dynamic global organization. As a Senior Corporate Counsel, you will play a pivotal role in ensuring our client's operations adhere to all relevant national and international laws and regulations. Your primary responsibilities will include conducting thorough legal research on emerging regulatory landscapes, drafting and implementing comprehensive compliance policies and procedures, and providing expert legal advice on a wide range of compliance matters. You will be instrumental in developing and delivering training programs to employees across various departments on regulatory best practices. This role requires a proactive approach to risk management, identifying potential legal issues before they arise and developing strategies to mitigate them.
The ideal candidate will possess a Juris Doctor (JD) degree from an accredited law school and be admitted to practice law in at least one relevant jurisdiction. A minimum of 7 years of progressive experience in corporate law, with a significant focus on regulatory compliance, financial services regulations, data privacy laws (e.g., GDPR, CCPA), and anti-money laundering (AML) regulations is essential. Proven experience in drafting and negotiating complex commercial contracts and advising on corporate governance matters will be highly regarded. You must demonstrate exceptional analytical skills, a keen attention to detail, and the ability to articulate complex legal concepts clearly and concisely, both in writing and verbally. Proficiency in legal research databases and standard office software is required. This role demands a strong ethical compass, integrity, and the ability to work independently and collaboratively in a fast-paced, remote environment. You will report directly to the General Counsel and work closely with cross-functional teams, including finance, operations, and human resources, to ensure seamless integration of compliance measures throughout the organization.
Responsibilities:
Qualifications:
The ideal candidate will possess a Juris Doctor (JD) degree from an accredited law school and be admitted to practice law in at least one relevant jurisdiction. A minimum of 7 years of progressive experience in corporate law, with a significant focus on regulatory compliance, financial services regulations, data privacy laws (e.g., GDPR, CCPA), and anti-money laundering (AML) regulations is essential. Proven experience in drafting and negotiating complex commercial contracts and advising on corporate governance matters will be highly regarded. You must demonstrate exceptional analytical skills, a keen attention to detail, and the ability to articulate complex legal concepts clearly and concisely, both in writing and verbally. Proficiency in legal research databases and standard office software is required. This role demands a strong ethical compass, integrity, and the ability to work independently and collaboratively in a fast-paced, remote environment. You will report directly to the General Counsel and work closely with cross-functional teams, including finance, operations, and human resources, to ensure seamless integration of compliance measures throughout the organization.
Responsibilities:
- Develop, implement, and maintain robust compliance programs.
- Provide legal guidance on regulatory changes and their impact on the business.
- Conduct internal investigations and respond to regulatory inquiries.
- Draft and review legal documents, policies, and contracts.
- Manage and mentor junior legal staff and external counsel.
- Advise on corporate governance and risk management strategies.
- Stay abreast of all relevant legal and regulatory developments.
Qualifications:
- Juris Doctor (JD) degree from a reputable law school.
- Admission to the bar in a recognized jurisdiction.
- Minimum of 7 years of relevant legal experience.
- Deep understanding of corporate law and regulatory frameworks.
- Excellent research, writing, and communication skills.
- Ability to manage multiple projects simultaneously.
- Proven ability to work effectively in a remote setting.
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5
Senior Aviation Regulatory Compliance Officer
00045 Manama, Capital
BHD105000 Annually
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Our client, a fast-growing aviation services company, is seeking a diligent and experienced Senior Aviation Regulatory Compliance Officer to join their team in **Manama, Capital, BH**. This position is responsible for ensuring that all company operations adhere to the stringent regulations set forth by national and international aviation authorities. The Senior Compliance Officer will monitor changes in aviation legislation, assess their impact on the company's procedures, and implement necessary updates. Key responsibilities include developing and maintaining compliance programs, conducting internal audits and assessments, and managing relationships with regulatory bodies. You will be tasked with reviewing operational procedures, training materials, and documentation to ensure ongoing compliance with aviation safety standards, airworthiness requirements, and operational certifications. The ideal candidate will possess a thorough understanding of aviation laws, regulations, and best practices relevant to aircraft operations, maintenance, and air traffic control. This role requires exceptional attention to detail, strong analytical skills, and the ability to interpret complex legal and regulatory texts. The Senior Aviation Regulatory Compliance Officer will also be involved in preparing for external audits and inspections. Excellent communication and interpersonal skills are necessary for collaborating with various departments and external stakeholders. A minimum of 7 years of experience in aviation regulatory compliance, safety management, or a related field is required. A Bachelor's degree in Aviation Management, Law, Public Administration, or a related discipline is essential. Knowledge of relevant aviation regulatory frameworks (e.g., ICAO, EASA, FAA, or GCAA) is mandatory. Experience with compliance management software and conducting internal audits is highly desirable. If you are a proactive compliance professional with a deep commitment to aviation safety and regulatory integrity, we invite you to apply.
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6
Senior Aviation Regulatory Compliance Specialist
7890 Askar, Southern
BHD7800 Annually
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Our client, a prominent player in the aviation sector, is seeking a highly knowledgeable and detail-oriented Senior Aviation Regulatory Compliance Specialist to join their team in **Tubli, Capital, BH**. This crucial role ensures that all aviation operations and activities adhere strictly to national and international aviation laws, regulations, and standards. The Specialist will be responsible for interpreting complex regulatory requirements, developing and implementing compliance programs, conducting internal audits, and providing expert guidance to operational teams. Key responsibilities include staying abreast of changes in aviation regulations, liaising with regulatory authorities, managing compliance documentation, and advising on best practices for safety and operational efficiency.
The ideal candidate will hold a Bachelor's degree in Aviation Management, Aerospace Engineering, Law, or a related field. Extensive experience (7+ years) in aviation regulatory compliance, airworthiness, or safety management is essential. A thorough understanding of international aviation standards (e.g., ICAO, EASA, FAA) and national aviation regulations is required. Experience in developing and implementing compliance management systems and conducting regulatory audits is a must. Strong analytical, research, and problem-solving skills are critical, along with excellent written and verbal communication abilities. The ability to manage multiple projects, prioritize tasks effectively, and work collaboratively with diverse teams is important. You should be adept at interpreting legal and regulatory texts and translating them into practical operational procedures. This is an excellent opportunity for a dedicated compliance professional to contribute to a leading aviation company and uphold the highest standards of safety and governance.
The ideal candidate will hold a Bachelor's degree in Aviation Management, Aerospace Engineering, Law, or a related field. Extensive experience (7+ years) in aviation regulatory compliance, airworthiness, or safety management is essential. A thorough understanding of international aviation standards (e.g., ICAO, EASA, FAA) and national aviation regulations is required. Experience in developing and implementing compliance management systems and conducting regulatory audits is a must. Strong analytical, research, and problem-solving skills are critical, along with excellent written and verbal communication abilities. The ability to manage multiple projects, prioritize tasks effectively, and work collaboratively with diverse teams is important. You should be adept at interpreting legal and regulatory texts and translating them into practical operational procedures. This is an excellent opportunity for a dedicated compliance professional to contribute to a leading aviation company and uphold the highest standards of safety and governance.
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7
Aviation Safety Inspector - Regulatory Compliance
234 Seef, Capital
BHD95000 Annually
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Posted 8 days ago
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A leading aviation authority is seeking a highly experienced and diligent Aviation Safety Inspector to ensure the highest standards of safety and regulatory compliance within the aviation sector in Seef, Capital, BH . This critical role involves conducting thorough inspections and audits of aircraft, airports, airlines, and maintenance organizations to ensure adherence to national and international aviation regulations. The ideal candidate will possess extensive knowledge of aviation safety management systems, airworthiness standards, and operational procedures. Responsibilities include evaluating safety protocols, identifying potential hazards, investigating incidents, and providing recommendations for corrective actions. Strong analytical skills, meticulous attention to detail, and the ability to interpret complex regulations are essential. You will play a vital role in maintaining the safety and security of air travel by upholding stringent standards and promoting a proactive safety culture across the industry. This position requires a commitment to aviation safety and a proven ability to work independently and make sound judgments.
Key Responsibilities:
Key Responsibilities:
- Conduct safety inspections and audits of aircraft, airfields, and aviation organizations.
- Ensure compliance with national and international aviation regulations and standards.
- Evaluate safety management systems (SMS) and operational procedures.
- Investigate aviation incidents, accidents, and occurrences to determine root causes.
- Identify safety deficiencies and recommend corrective actions to mitigate risks.
- Prepare detailed inspection reports and documentation.
- Provide technical guidance and expertise on aviation safety matters.
- Promote a strong safety culture within the aviation industry.
- Stay current with evolving aviation regulations and safety best practices.
- Bachelor's degree in Aviation Management, Aerospace Engineering, or a related field.
- Minimum of 7 years of experience in aviation operations, safety management, or regulatory compliance.
- Possession of relevant aviation certifications or licenses (e.g., Commercial Pilot License, Aircraft Maintenance Engineer License) is highly desirable.
- In-depth knowledge of ICAO standards, EASA/FAA regulations, and aviation safety principles.
- Proven experience with safety management systems (SMS) and risk assessment.
- Excellent analytical, problem-solving, and decision-making skills.
- Strong report writing and communication abilities.
- Ability to work independently and manage multiple tasks effectively.
- Willingness to travel as required.
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8
Senior Aviation Safety Inspector - Regulatory Compliance
222 Northern, Northern
BHD98000 Annually
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Our client, a leading aviation regulatory body, is seeking a highly experienced Senior Aviation Safety Inspector to ensure compliance with stringent safety standards across the aviation sector. This is a fully remote role, allowing you to contribute your expertise in aviation safety and regulatory oversight from anywhere. You will be responsible for conducting comprehensive inspections, audits, and investigations of aircraft operators, maintenance organizations, and other aviation-related entities. The ideal candidate will possess extensive knowledge of aviation regulations, aircraft systems, maintenance procedures, and safety management systems.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Conduct thorough safety inspections and audits of aviation operators, maintenance facilities, and certified personnel.
- Investigate aviation incidents and accidents to determine root causes and recommend corrective actions.
- Ensure compliance with national and international aviation safety regulations and standards.
- Review and approve aviation safety management systems (SMS) and operational procedures.
- Assess pilot and maintenance technician qualifications and certifications.
- Develop and deliver aviation safety training programs and seminars.
- Prepare detailed inspection reports, findings, and recommendations.
- Collaborate with aviation authorities and industry stakeholders on safety initiatives.
- Stay abreast of emerging aviation safety trends, technologies, and regulatory changes.
- Provide expert advice and guidance on aviation safety matters.
- Participate in the development and revision of aviation safety regulations and policies.
- Maintain accurate records of inspections, investigations, and certifications.
Qualifications:
- Bachelor's degree in Aviation Management, Aerospace Engineering, Aeronautical Science, or a related field.
- Minimum of 8 years of experience in aviation safety, operations, or maintenance.
- Extensive knowledge of aviation regulations (e.g., ICAO Annexes, FAA/EASA regulations).
- Experience in conducting aviation audits, inspections, and incident investigations.
- Strong understanding of aircraft systems, maintenance practices, and safety management systems (SMS).
- Possession of relevant aviation certifications (e.g., Airframe & Powerplant (A&P) license, pilot license, certified safety auditor) is highly desirable.
- Excellent analytical, critical thinking, and problem-solving skills.
- Exceptional written and verbal communication skills, with the ability to produce clear and concise reports.
- Demonstrated ability to work independently and manage workload effectively in a remote environment.
- Strong ethical standards and a commitment to aviation safety.
- Experience with regulatory compliance in a global context is a plus.
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