53 Regulatory Affairs Manager jobs in Bahrain
Pharmaceutical Regulatory Affairs Manager
80501 Isa Town, Northern
BHD100000 Annually
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Posted 1 day ago
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Job Description
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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Senior Pharmaceutical Regulatory Affairs Manager
2015 Al Seef
BHD105000 Annually
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Posted 10 days ago
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Job Description
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:
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**.
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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1
Clinical Trials Manager
234 Galali
BHD88000 Annually
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Posted 1 day ago
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Our client is seeking a dynamic and experienced Clinical Trials Manager to oversee the planning, execution, and completion of clinical studies within the pharmaceutical industry. This hybrid role requires a candidate who can effectively manage projects both on-site and remotely, ensuring compliance with regulatory standards and company policies. The successful applicant will be responsible for the day-to-day management of clinical trials, including site selection, budget management, data collection, and vendor oversight. You will liaise with principal investigators, clinical research associates, and other stakeholders to ensure studies are conducted in accordance with approved protocols.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Develop and implement clinical trial protocols and project plans.
- Manage study budgets, timelines, and resources effectively.
- Ensure adherence to Good Clinical Practice (GCP) and other relevant regulatory guidelines.
- Oversee the recruitment and training of site staff and clinical research associates (CRAs).
- Monitor study progress and identify potential risks, implementing mitigation strategies as needed.
- Collaborate with data management teams to ensure accurate and timely data collection and reporting.
- Prepare study reports and contribute to regulatory submissions.
- Communicate effectively with internal teams, investigators, and external vendors.
Qualifications:
- Bachelor's degree in a life science, nursing, or related field; Master's degree preferred.
- Minimum of 4 years of experience in clinical trial management within the pharmaceutical or biotechnology sector.
- Strong understanding of ICH-GCP guidelines and regulatory requirements.
- Proven experience in managing multiple clinical trials simultaneously.
- Excellent leadership, project management, and communication skills.
- Ability to work effectively in a hybrid environment, balancing remote and in-office responsibilities.
- Proficiency in clinical trial management software and tools.
- Experience with specific therapeutic areas is a plus.
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2
Clinical Research Associate - Pharmaceutical Trials
11223 Hamad Town, Northern
BHD85000 Annually
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Posted today
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Job Description
Our client, a leading pharmaceutical company, is seeking a dedicated and experienced Clinical Research Associate (CRA) to support their ongoing clinical trials. This hybrid role involves a combination of remote work and on-site visits to clinical trial sites. You will be integral in ensuring the quality, integrity, and timely completion of clinical studies, adhering to strict regulatory guidelines.
Key Responsibilities:
The ideal candidate will possess a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotechnology industry is required. Comprehensive knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials is essential. Demonstrated experience in monitoring clinical trials and performing site visits is mandatory. Excellent communication, organizational, and interpersonal skills are necessary. The ability to travel to clinical sites as required is crucial for this hybrid role. Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is highly desirable. This position plays a vital role in bringing new medicines to patients. The primary focus area is around Hamad Town, Northern, BH .
Key Responsibilities:
- Performing site selection, initiation, monitoring, and close-out visits to clinical trial sites.
- Ensuring that all study conduct adheres to the approved protocol, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines.
- Verifying the accuracy, completeness, and consistency of clinical data through source document verification.
- Monitoring patient safety and reporting adverse events according to regulatory requirements.
- Managing communication between the sponsor, clinical investigators, and site staff.
- Ensuring timely submission of essential study documents.
- Identifying, tracking, and resolving site-related issues and deviations.
- Training and mentoring site staff on protocol requirements and data collection procedures.
- Preparing and presenting study progress reports to internal stakeholders.
- Maintaining accurate and up-to-date trial master files and site files.
The ideal candidate will possess a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A minimum of 3 years of experience as a Clinical Research Associate or in a similar role within the pharmaceutical or biotechnology industry is required. Comprehensive knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trials is essential. Demonstrated experience in monitoring clinical trials and performing site visits is mandatory. Excellent communication, organizational, and interpersonal skills are necessary. The ability to travel to clinical sites as required is crucial for this hybrid role. Proficiency with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is highly desirable. This position plays a vital role in bringing new medicines to patients. The primary focus area is around Hamad Town, Northern, BH .
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3
Clinical Research Associate - Pharmaceutical Trials
217 Busaiteen, Muharraq
BHD75000 Annually
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Posted 9 days ago
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Our client, a leading pharmaceutical company, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to manage and monitor clinical trials. This role plays a vital part in the drug development process, ensuring the integrity, accuracy, and compliance of trial data. The CRA will be responsible for site selection, initiation, monitoring, and close-out visits for clinical trial sites. You will ensure that trials are conducted, recorded, and reported in accordance with the protocol, company policies, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) guidelines. Key duties include verifying source data, ensuring subject safety, managing investigational product accountability, and resolving data queries. The ideal candidate will possess strong knowledge of clinical trial processes, regulatory requirements, and medical terminology. Excellent organizational, communication, and interpersonal skills are essential for building effective relationships with investigators, site staff, and internal teams. This position requires the ability to travel to trial sites as needed. The role offers a hybrid work arrangement, balancing remote administrative tasks with essential on-site monitoring and client engagement. This position is based in **Busaiteen, Muharraq, BH**. A Bachelor's degree in a life science, nursing, or a related field is required, along with at least 3 years of direct experience as a Clinical Research Associate monitoring pharmaceutical trials.
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4
Clinical Research Associate - Pharmaceutical Trials
705 Zallaq, Southern
BHD70000 Annually
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Posted 17 days ago
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Job Description
Our client, a leading pharmaceutical company, is looking for a dedicated and meticulous Clinical Research Associate (CRA) to support the execution of clinical trials. This role plays a critical part in ensuring the integrity and accuracy of data collected during research studies, adhering to strict regulatory guidelines and protocols. You will be responsible for site selection, initiation, monitoring, and close-out visits to ensure compliance with Good Clinical Practice (GCP) and study protocols. The ideal candidate will have a strong background in clinical research, excellent organizational skills, and a keen attention to detail. You will build and maintain effective relationships with investigators and site staff, providing training and ongoing support. Responsibilities include reviewing patient records, verifying data accuracy, ensuring proper drug accountability, and resolving data discrepancies. You will also be involved in preparing regulatory submission documents and contributing to study close-out activities. A bachelor's degree in a life science or healthcare-related field is required, along with proven experience as a CRA or in a similar clinical research role. Excellent communication, problem-solving, and interpersonal skills are essential. This hybrid position will require travel to clinical sites, with opportunities for remote work in between visits. We are committed to advancing medical research and seeking passionate individuals to join our team in Zallaq, Southern, BH .
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5
Senior Drug Safety Physician
212 Northern, Northern
BHD160000 Annually
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Posted 8 days ago
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Job Description
Our client, a pioneering pharmaceutical company dedicated to advancing global health, is seeking a highly accomplished Senior Drug Safety Physician to join their critical Pharmacovigilance department. This role is essential in safeguarding public health by meticulously evaluating and managing the safety profiles of our client's pharmaceutical products throughout their lifecycle. You will be responsible for the medical assessment of adverse event reports, contributing to risk management strategies, and ensuring compliance with global regulatory safety requirements. The ideal candidate will possess extensive experience in clinical medicine and pharmacovigilance, with a deep understanding of drug safety principles and regulatory landscapes.
Responsibilities:
Responsibilities:
- Provide medical expertise for the assessment of adverse event reports, including causality assessment and case narrative review.
- Contribute to the preparation of aggregate safety reports (e.g., Periodic Benefit-Risk Evaluation Reports - PBRERs, DSURs).
- Participate in the development and review of risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS).
- Oversee signal detection and evaluation activities, collaborating with cross-functional teams to assess potential safety signals.
- Serve as the medical expert during regulatory agency interactions related to drug safety.
- Review and provide medical input on clinical trial protocols and investigator brochures from a safety perspective.
- Contribute to the development and implementation of pharmacovigilance policies and procedures.
- Mentor and guide junior physicians and safety scientists within the department.
- Stay current with evolving global regulatory requirements and industry best practices in pharmacovigilance.
- Participate in safety governance committees and contribute to the overall safety strategy of assigned products.
- Medical Doctor (MD) or equivalent medical degree.
- Board certification or eligibility in a relevant specialty is highly desirable.
- Minimum of 7 years of experience in pharmacovigilance and drug safety within the pharmaceutical industry or a related regulatory setting.
- In-depth knowledge of global regulatory requirements for drug safety (e.g., FDA, EMA).
- Strong understanding of clinical trial methodology and data interpretation.
- Excellent medical judgment and analytical skills.
- Proven ability to conduct rigorous scientific and medical assessments.
- Exceptional written and verbal communication skills, with the ability to present complex medical information effectively.
- Experience in signal detection and management.
- Ability to work collaboratively in a multidisciplinary team environment.
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6
Pharmacovigilance Scientist, Drug Safety
11223 Southern, Southern
BHD95000 Annually
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Posted 15 days ago
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Job Description
Our client is actively seeking a highly skilled and motivated Pharmacovigilance Scientist to join their dedicated drug safety team. This critical role involves monitoring and evaluating the safety of pharmaceutical products throughout their lifecycle, ensuring patient safety and regulatory compliance. The ideal candidate will possess a strong scientific background, a keen analytical mind, and extensive knowledge of pharmacovigilance principles and regulatory requirements. You will be responsible for the collection, assessment, and reporting of adverse event data, contributing to the overall safety profile of our client's pharmaceutical portfolio. This role requires a meticulous approach to data analysis and a commitment to upholding the highest standards of drug safety.
Responsibilities:
This position is predominantly remote, allowing for flexible working arrangements. A minimum of a Bachelor's degree in a life science, pharmacy, nursing, or a related field is required; an advanced degree (MSc, PhD, PharmD) is highly preferred. At least 4 years of experience in pharmacovigilance or drug safety is essential. Comprehensive knowledge of ICH guidelines, GVP regulations, and global reporting requirements is mandatory. Excellent analytical, problem-solving, and written/verbal communication skills are crucial. Experience with safety databases (e.g., Argus, ARISg) is a significant advantage. Join a team committed to ensuring the safety and well-being of patients worldwide.
Responsibilities:
- Collect, review, and process adverse event reports from various sources, ensuring accuracy and completeness.
- Perform medical assessment of adverse event data, including causality evaluation and seriousness determination.
- Contribute to the preparation and submission of regulatory safety reports, such as Periodic Adverse Drug Experience Reports (PADERs) and Development Safety Update Reports (DSURs).
- Participate in signal detection activities, identifying potential safety issues through data analysis.
- Collaborate with clinical development, regulatory affairs, and medical affairs teams on safety-related matters.
- Contribute to the development and maintenance of safety databases and pharmacovigilance systems.
- Support the authoring of aggregate safety reports and risk management plans.
- Ensure compliance with global regulatory requirements and internal SOPs related to pharmacovigilance.
- Conduct literature reviews to identify relevant safety information and emerging trends.
- Provide scientific input and expertise on drug safety matters to cross-functional teams.
This position is predominantly remote, allowing for flexible working arrangements. A minimum of a Bachelor's degree in a life science, pharmacy, nursing, or a related field is required; an advanced degree (MSc, PhD, PharmD) is highly preferred. At least 4 years of experience in pharmacovigilance or drug safety is essential. Comprehensive knowledge of ICH guidelines, GVP regulations, and global reporting requirements is mandatory. Excellent analytical, problem-solving, and written/verbal communication skills are crucial. Experience with safety databases (e.g., Argus, ARISg) is a significant advantage. Join a team committed to ensuring the safety and well-being of patients worldwide.
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7
Lead Clinical Research Associate - Oncology Trials
710 Isa Town, Northern
BHD100000 Annually
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Posted 1 day ago
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Our client, a leading global pharmaceutical company, is looking for an experienced and highly motivated Lead Clinical Research Associate (CRA) to oversee critical oncology clinical trials. This position is designed for a seasoned professional who thrives in a dynamic, research-driven environment and can effectively manage multiple aspects of clinical research remotely. As a fully remote role, you will leverage cutting-edge technology to ensure the integrity, accuracy, and efficiency of our clinical data, collaborating with site staff, investigators, and internal teams worldwide.
Responsibilities:
Responsibilities:
- Serve as the primary point of contact for assigned clinical trial sites, ensuring adherence to study protocols, GCP guidelines, and regulatory requirements.
- Conduct comprehensive site selection, initiation, monitoring, and close-out visits (remote or on-site as needed), documenting findings and ensuring timely resolution of action items.
- Train and mentor junior CRAs and site personnel on study-specific procedures, regulatory requirements, and data collection standards.
- Oversee data management activities, including review of source documents, case report forms (CRFs), and query resolution to ensure data accuracy and completeness.
- Monitor trial progress, identify potential risks and issues, and implement corrective and preventive actions (CAPAs).
- Prepare and present study progress reports to internal stakeholders and participate in team meetings.
- Ensure all study-related documentation is maintained accurately and filed in accordance with company policies and regulatory guidelines.
- Collaborate with cross-functional teams, including project managers, data managers, biostatisticians, and medical monitors, to ensure successful trial execution.
- Contribute to the development and review of study protocols, informed consent forms, and other essential study documents.
- Stay current with industry best practices, therapeutic area advancements, and regulatory updates in oncology research.
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degree (MSc, PhD) or equivalent experience is a plus.
- Minimum of 5-7 years of experience as a Clinical Research Associate, with at least 2 years in a lead or senior CRA capacity.
- Extensive experience in oncology clinical trials, with a strong understanding of cancer biology and treatment modalities.
- In-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant international regulatory requirements.
- Proven ability to conduct remote monitoring and effectively manage sites from a distance.
- Excellent verbal and written communication, organizational, and interpersonal skills.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Strong problem-solving skills and the ability to work independently with minimal supervision.
- Demonstrated leadership potential and experience mentoring junior staff.
- Availability to travel occasionally for essential on-site activities if required.
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8
Senior Clinical Research Associate - Oncology Trials
2215 Al Muharraq
BHD90000 Annually
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Posted 3 days ago
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Job Description
Our client, a leading pharmaceutical company dedicated to developing life-changing therapies, is seeking an experienced Senior Clinical Research Associate (CRA) to manage and oversee complex oncology clinical trials. This position is based in Sitra, Capital, BH and offers a hybrid work model, combining on-site responsibilities with remote flexibility. The Senior CRA will play a crucial role in ensuring the efficient and compliant execution of clinical trials, from site initiation to close-out. You will be responsible for monitoring clinical trial sites to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This involves verifying data accuracy, managing site personnel, and resolving any issues that may arise during the trial. The ideal candidate will possess a strong understanding of oncology research, excellent analytical and problem-solving skills, and a proven ability to build effective relationships with investigators and site staff. You will conduct site visits, including routine monitoring, initiation visits, and close-out visits, and will prepare detailed monitoring reports. We are looking for a highly organized and detail-oriented individual with a commitment to patient safety and data integrity. Experience in managing multi-center trials and working with electronic data capture (EDC) systems is essential. This role demands excellent communication skills, both written and verbal, and the ability to effectively manage your territory and travel. You will also be involved in training new CRAs and contributing to the continuous improvement of clinical operations. If you are passionate about advancing cancer treatment and have the expertise to ensure the successful conduct of critical clinical studies, we invite you to apply.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Conduct site initiation, routine monitoring, and close-out visits for clinical trials.
- Ensure compliance with study protocols, GCP, and regulatory requirements.
- Verify the accuracy, completeness, and integrity of clinical trial data.
- Manage relationships with clinical trial sites, investigators, and study coordinators.
- Prepare and present comprehensive monitoring visit reports.
- Oversee the informed consent process and patient safety monitoring.
- Ensure timely resolution of site issues and deviations.
- Manage essential trial documents and site files.
- Participate in the selection and qualification of new clinical trial sites.
- Contribute to the training and mentorship of junior CRAs.
Qualifications:
- Bachelor's degree in a life science, nursing, or a related field; advanced degree preferred.
- Minimum of 5 years of experience as a Clinical Research Associate, with a strong focus on oncology.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
- Proven experience with EDC systems and clinical trial management software.
- Excellent understanding of medical terminology and clinical trial processes.
- Strong analytical and problem-solving skills.
- Exceptional organizational and time management abilities.
- Effective communication, interpersonal, and negotiation skills.
- Willingness to travel extensively to assigned sites.
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