Job Description
Position:Regulatory Affairs Manager
Company:GlaxoSmithKline
Location:Beau Bassin, Mauritius
Experience:5-7 years
Education:Bachelor’s degree in Pharmacy, Life Sciences or related field
Employment Type:Full-time
Industry:Pharmaceuticals
Department:Regulatory Affairs
Salary:SSP 800,000 – 1,200,000 per annum
Vacancies:1
Company Overview
GlaxoSmithKline (GSK) is a global healthcare company with a strong presence in Mauritius, dedicated to improving the quality of life through innovative medicines, vaccines, and consumer health products. With a commitment to scientific excellence and ethical standards, GSK has built a reputation for delivering high‑impact health solutions across the world. The Beau Bassin site serves as a strategic hub for regional regulatory activities, supporting product registrations, compliance monitoring, and market access initiatives throughout the African and Indian Ocean regions. As part of its ongoing expansion, GSK continues to invest in talent, technology, and sustainable practices, making it an attractive employer for professionals seeking meaningful career opportunities in Mauritius. This role contributes directly to GSK’s mission of delivering safe and effective pharmaceutical products to patients, reinforcing the company’s position as a leader in the global health sector.
Job Overview
The Regulatory Affairs Manager will lead the end‑to‑end regulatory strategy for GSK’s portfolio of pharmaceutical products marketed in Mauritius and neighboring territories. Reporting to the Head of Regulatory Affairs, you will collaborate with cross‑functional teams including Clinical Development, Quality Assurance, Manufacturing, and Commercial Operations to ensure timely product approvals, maintain compliance with local and international regulations, and support market expansion initiatives. This position offers a unique opportunity to influence regulatory pathways, engage with health authorities, and drive strategic decisions that impact patient access to life‑saving medicines. For more information about GSK’s commitment to career growth, visit https://mauritiusjobsearch.com/.
Key Responsibilities
- Develop and execute regulatory strategies for new product registrations, variations, and renewals in Mauritius and selected regional markets.
- Prepare, review, and submit dossiers to the Ministry of Health and Quality of Life, ensuring compliance with local guidelines and ICH standards.
- Act as the primary liaison with health authorities, managing queries, inspections, and negotiations to achieve favorable outcomes.
- Lead cross‑functional regulatory projects, coordinating with Clinical, Quality, Manufacturing, and Commercial teams to align timelines and deliverables.
- Monitor changes in regulatory legislation, guidelines, and industry trends, providing proactive guidance to internal stakeholders.
- Maintain the regulatory intelligence database and ensure accurate documentation of all regulatory activities.
- Support post‑marketing surveillance activities, including adverse event reporting and product lifecycle management.
- Mentor junior regulatory staff, fostering a culture of continuous learning and compliance excellence.
Required Skills
- In‑depth knowledge of Mauritian pharmaceutical regulations, ICH guidelines, and global regulatory frameworks.
- Strong analytical and problem‑solving abilities with a detail‑oriented approach.
- Excellent written and verbal communication skills, capable of preparing clear and concise regulatory submissions.
- Proven project management experience, with the ability to lead multiple initiatives simultaneously.
- Negotiation and stakeholder management skills, especially with health authorities and internal teams.
- Proficiency in regulatory software tools and Microsoft Office Suite.
- Ability to work independently and as part of a diverse, multicultural team.
Education
A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Advanced degrees (MSc, PhD) or professional certifications in regulatory affairs are highly desirable and will be considered an asset.
Experience
Applicants must have 5‑7 years of progressive experience in regulatory affairs within the pharmaceutical industry, with a proven track record of successful product registrations and interactions with health authorities. Experience in an international or multi‑regional regulatory environment is preferred.
Salary
The compensation package ranges from SSP 800,000 to SSP 1,200,000 per year, commensurate with experience and qualifications. The package includes performance‑based bonuses, health insurance, and retirement benefits.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Retirement savings plan with company matching contributions.
- Generous paid time off and public holidays.
- Professional development allowance and tuition reimbursement.
- Employee assistance program and wellness initiatives.
- Flexible working arrangements and remote work options where applicable.
Training
- On‑boarding program covering GSK’s regulatory processes, compliance standards, and corporate culture.
- Access to GSK’s global learning platform for continuous skill enhancement.
- Mentorship from senior regulatory leaders and participation in industry conferences.
- Regular internal workshops on regulatory intelligence, risk management, and emerging trends.
Working Environment
GSK offers a collaborative, inclusive, and innovative workplace where diversity of thought is celebrated. The Beau Bassin office provides modern facilities, state‑of‑the‑art technology, and a supportive environment that encourages teamwork and personal growth. Employees benefit from a culture that values safety, integrity, and sustainability, aligning with GSK’s global commitment to responsible business practices.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the GSK careers 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 Beau Bassin location.
Equal Opportunity Statement
GlaxoSmithKline is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.