Job Description
Position:Regulatory Affairs Specialist
Company:GlaxoSmithKline Sierra Leone
Location:Bonthe, Sierra Leone
Experience:3-5 years in pharmaceutical regulatory affairs
Education:Bachelor’s degree in Pharmacy, Life Sciences, or related field
Employment Type:Full-time
Industry:Pharmaceuticals
Department:Regulatory Affairs
Salary:SSP 1,200,000 – 1,800,000 per month
Vacancies:1
Company Overview
GlaxoSmithKline Sierra Leone is a leading global healthcare company dedicated to improving the health and well-being of people worldwide. With a strong presence across Africa, GSK brings innovative medicines, vaccines, and consumer health products to local markets. In Sierra Leone, the company collaborates with the Ministry of Health, local distributors, and community health programs to ensure access to high‑quality pharmaceutical solutions. As part of GSK’s commitment to sustainable development, the Bonthe office plays a strategic role in supporting regional regulatory compliance, product registration, and market entry strategies. The organization values integrity, scientific excellence, and a diverse workforce, offering a dynamic environment where professionals can grow while contributing to public health outcomes. This position aligns with GSK’s mission to deliver life‑changing medicines and supports the broader goal of enhancing healthcare infrastructure in Sierra Leone.
Job Overview
The Regulatory Affairs Specialist will be responsible for managing the end‑to‑end registration process of pharmaceutical products in Sierra Leone, ensuring compliance with local and international regulations. Working closely with cross‑functional teams, the specialist will prepare dossiers, liaise with the National Medicines Regulatory Authority, and monitor legislative changes that impact product lifecycle. This role is pivotal in safeguarding product quality, facilitating market access, and supporting GSK’s strategic objectives in the region. Candidates will have the opportunity to engage with senior stakeholders, contribute to policy discussions, and play a key role in expanding GSK’s portfolio in West Africa. For more information about GSK’s commitment to health innovation, visit our career portal.
Key Responsibilities
- Prepare, compile, and submit regulatory dossiers for new product registrations and variations.
- Maintain ongoing communication with the National Medicines Regulatory Authority and other relevant agencies.
- Monitor and interpret changes in pharmaceutical legislation, guidelines, and standards.
- Develop and implement regulatory strategies that align with business objectives and timelines.
- Provide regulatory guidance to research, development, manufacturing, and commercial teams.
- Ensure all product labeling, packaging, and advertising materials meet local compliance requirements.
- Conduct internal audits and support external inspections to verify regulatory adherence.
- Maintain accurate records of submissions, approvals, and correspondence.
Required Skills
- Strong knowledge of Sierra Leone’s pharmaceutical regulatory framework and WHO guidelines.
- Excellent written and verbal communication skills for drafting dossiers and interacting with authorities.
- Analytical mindset with the ability to interpret complex regulatory documents.
- Project management expertise to handle multiple submissions simultaneously.
- Proficiency in Microsoft Office Suite and regulatory software tools.
- Attention to detail and high level of accuracy in documentation.
- Ability to work collaboratively in a multicultural team environment.
Education
A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Advanced certifications in regulatory affairs (e.g., RAC, RAPS) are considered an asset.
Experience
Applicants must have 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to African market submissions. Experience interacting with national regulatory bodies and managing product life‑cycle activities is essential.
Salary
The position offers a competitive salary range of SSP 1,200,000 to 1,800,000 per month, commensurate with experience and qualifications. Performance‑based incentives and annual reviews are part of the compensation package.
Benefits
- Comprehensive health insurance covering employee and dependents.
- Retirement savings plan with employer contributions.
- Generous paid leave, including annual, sick, and parental leave.
- Professional development allowance for certifications and conferences.
- Employee assistance program and wellness initiatives.
Training
- Onboarding program covering GSK’s compliance standards and corporate culture.
- Continuous regulatory training modules to stay updated on legislative changes.
- Mentorship opportunities with senior regulatory leaders.
- Access to internal e‑learning platforms for skill enhancement.
Working Environment
The Bonthe office provides a collaborative, inclusive, and safety‑focused workspace. Employees benefit from modern facilities, flexible working arrangements, and a culture that encourages innovation and knowledge sharing. GSK promotes a healthy work‑life balance and supports community engagement initiatives throughout Sierra Leone.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment at the Bonthe office.
Equal Opportunity Statement
GlaxoSmithKline Sierra Leone is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of race, gender, age, disability, religion, or sexual orientation. All qualified applicants will receive consideration for employment without discrimination.