Pharmaceutical Regulatory Affairs Manager Job Vacancy in Bwiam, Gambia – Pharmaceutical Regulatory Compliance

Job Description

Position: Pharmaceutical Regulatory Affairs Manager

Company: Johnson & Johnson Gambia

Location: Bwiam, Gambia

Experience: Minimum 7 years in pharmaceutical regulatory affairs with at least 3 years in a managerial role

Education: Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or related field; Master’s degree or regulatory affairs certification preferred

Employment Type: Full-time

Industry: Pharmaceutical Regulatory Compliance

Department: Regulatory Affairs

Vacancies:1

Company Overview

Johnson & Johnson Gambia is a leading global healthcare company committed to improving health and well-being through innovative pharmaceutical products, medical devices, and consumer health solutions. As part of the world’s largest and most diversified healthcare company, our Gambia operations focus on bringing life-changing medicines and healthcare solutions to communities across the country. With a legacy spanning over 130 years, Johnson & Johnson operates in more than 60 countries and maintains a strong presence in Africa through its commitment to advancing healthcare accessibility and quality. Our Gambia office serves as a regional hub for regulatory excellence, ensuring that our pharmaceutical products meet the highest standards of safety, efficacy, and quality while complying with local and international regulations. We are dedicated to creating a healthier Gambia through strategic partnerships with healthcare providers, regulatory authorities, and community organizations.

At Johnson & Johnson Gambia, we believe in the power of diverse perspectives and inclusive collaboration to drive healthcare innovation. Our company culture emphasizes integrity, scientific excellence, and patient-centered care, making us an employer of choice for healthcare professionals seeking meaningful careers. We invest significantly in local talent development, regulatory capacity building, and community health initiatives that align with Gambia’s national healthcare priorities. As we expand our regulatory operations in West Africa, we are seeking a Pharmaceutical Regulatory Affairs Manager to lead our compliance efforts and ensure timely market access for our life-saving medicines. This position represents an exceptional opportunity to join a global healthcare leader while making a tangible impact on public health outcomes in Gambia.

Job Overview

The Pharmaceutical Regulatory Affairs Manager will lead all regulatory activities for Johnson & Johnson’s pharmaceutical portfolio in Gambia, ensuring compliance with the Medicines Control Agency (MCA) requirements and international regulatory standards. This senior role involves developing and executing regulatory strategies for product registration, maintaining marketing authorizations, and managing regulatory submissions throughout the product lifecycle. The successful candidate will serve as the primary liaison between Johnson & Johnson and Gambian regulatory authorities, providing expert guidance on regulatory requirements and ensuring timely approvals for new products and indications.

This position offers a unique opportunity to shape the regulatory landscape for pharmaceutical products in Gambia while working with a diverse portfolio of innovative medicines. The Regulatory Affairs Manager will collaborate closely with regional and global regulatory teams, cross-functional business units, and external stakeholders to ensure regulatory compliance and facilitate patient access to essential medications. This role requires a strategic thinker with deep regulatory expertise, strong leadership capabilities, and a commitment to advancing healthcare in Gambia. For more information about Gambia Jobs and career opportunities in the pharmaceutical sector, visit our dedicated job portal.

Key Responsibilities

• Develop and implement comprehensive regulatory strategies for new product registrations, line extensions, and variations in compliance with Gambian regulations
• Prepare, review, and submit high-quality regulatory dossiers to the Medicines Control Agency and other relevant authorities
• Maintain all product licenses and marketing authorizations, ensuring timely renewals and compliance with post-approval requirements
• Monitor and interpret evolving regulatory requirements in Gambia and provide strategic guidance to internal stakeholders
• Lead regulatory intelligence activities, tracking changes in legislation and guidelines that may impact company operations
• Manage regulatory inspections, audits, and queries from health authorities, coordinating appropriate responses and corrective actions
• Collaborate with quality assurance, pharmacovigilance, and medical affairs teams to ensure integrated regulatory compliance
• Develop and maintain positive relationships with regulatory authorities, industry associations, and key opinion leaders
• Train and mentor junior regulatory affairs staff, fostering a culture of regulatory excellence and continuous improvement
• Participate in regional regulatory initiatives and contribute to the development of harmonized regulatory approaches in West Africa

Required Skills

• Expert knowledge of Gambian pharmaceutical regulations and registration procedures
• Proven experience in preparing CTD format regulatory submissions for pharmaceutical products
• Strong understanding of ICH guidelines, GMP requirements, and quality management systems
• Excellent project management skills with ability to manage multiple regulatory projects simultaneously
• Outstanding communication and negotiation skills for effective interaction with regulatory authorities
• Strategic thinking and problem-solving abilities in complex regulatory environments
• Leadership capabilities with experience in managing regulatory teams and cross-functional collaboration
• Attention to detail and commitment to regulatory compliance and quality standards
• Proficiency in regulatory information management systems and document management tools
• Ability to analyze scientific data and translate technical information into regulatory strategies

Education

Candidates must possess a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific field from an accredited institution. A Master’s degree in Regulatory Affairs, Pharmaceutical Sciences, or Business Administration is highly preferred. Professional certifications such as RAC (Regulatory Affairs Certification) or equivalent international regulatory qualifications will be considered a significant advantage. Additional training in pharmacovigilance, quality management systems, or clinical research is desirable. Candidates should demonstrate continuous professional development in regulatory affairs through relevant courses, workshops, or conferences.

Experience

The ideal candidate will have a minimum of 7 years of progressive experience in pharmaceutical regulatory affairs, with at least 3 years in a managerial or leadership role. Experience must include direct responsibility for regulatory submissions in Gambia or similar African markets, with demonstrated success in obtaining marketing authorizations for pharmaceutical products. Candidates should have comprehensive knowledge of the Medicines Control Agency requirements and procedures, along with experience interacting with regulatory authorities. Previous work in multinational pharmaceutical companies and exposure to global regulatory processes will be highly valued. Experience in therapeutic areas such as oncology, immunology, infectious diseases, or cardiovascular medicine is advantageous.

Benefits

• Competitive salary package with performance-based incentives
• Comprehensive health insurance coverage for employee and dependents
• Professional development opportunities and regulatory training programs
• Retirement savings plan with company matching contributions
• Annual leave with additional company holidays
• Relocation assistance for qualified candidates moving to Bwiam
• Opportunities for international exposure and career advancement within Johnson & Johnson
• Employee wellness programs and work-life balance initiatives
• Access to cutting-edge regulatory tools and resources

Training

• Comprehensive onboarding program covering Johnson & Johnson regulatory processes and systems
• Specialized training in Gambian pharmaceutical regulations and submission requirements
• Access to global regulatory affairs training modules and certification programs
• Leadership development programs for managerial skill enhancement
• Regular workshops on emerging regulatory trends and compliance updates
• Cross-functional training opportunities with quality, medical, and commercial teams
• Mentorship program with senior regulatory professionals

Working Environment

The Pharmaceutical Regulatory Affairs Manager will work in a modern, well-equipped office environment in Bwiam, with access to advanced regulatory tools and collaborative workspaces. The role involves a combination of independent work and team collaboration, with regular interactions with regional and global colleagues. The position may require occasional travel within Gambia for regulatory meetings and limited international travel for training and conferences. Johnson & Johnson Gambia promotes a culture of innovation, integrity, and inclusion, where employees are encouraged to bring their authentic selves to work and contribute to meaningful healthcare solutions. The company supports flexible work arrangements where business needs allow, recognizing the importance of work-life balance in sustaining high performance.

Application Process

Interested candidates should submit a comprehensive CV and cover letter detailing their regulatory experience and qualifications through the Johnson & Johnson careers portal. Applications will be reviewed on a rolling basis until the position is filled. Shortlisted candidates will undergo a multi-stage selection process including initial screening, technical assessments, and interviews with regulatory leadership. Reference checks and background verification will be conducted for final candidates. Johnson & Johnson Gambia is committed to a fair and transparent recruitment process that identifies the most qualified candidates based on merit and potential. For additional Job Vacancy in Gambia opportunities and regional career information, explore our partner platforms.

Equal Opportunity Statement

Johnson & Johnson Gambia is an equal opportunity employer committed to diversity and inclusion in the workplace. We value and respect the unique perspectives and experiences that individuals from different backgrounds bring to our organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or any other characteristic protected by applicable laws. We are dedicated to providing reasonable accommodations for applicants with disabilities throughout the recruitment process. Johnson & Johnson Gambia fosters an inclusive environment where all employees can thrive and contribute to our mission of advancing healthcare in Gambia. Discover more Career Opportunities in Gambia and across the region through our network of employment resources.