Job Description
Position: Regulatory Affairs Manager
Company: GlaxoSmithKline (GSK)
Location: Goodlands, Mauritius
Experience: 8+ years in pharmaceutical regulatory affairs
Education: Master’s degree in Pharmacy, Life Sciences, or related field
Employment Type: Full-time
Industry: Pharmaceuticals
Department: Regulatory Affairs
Salary: SSP 900,000 – 1,200,000 per annum
Vacancies:1
Company Overview
GlaxoSmithKline (GSK) is a global healthcare leader dedicated to improving the quality of life through innovative medicines, vaccines, and consumer healthcare products. With a strong presence in over 150 countries, GSK operates a state‑of‑the‑art manufacturing and research hub in Mauritius, contributing significantly to the island’s economy and offering world‑class career pathways. The Goodlands facility focuses on the development, production, and regulatory compliance of high‑quality pharmaceutical products destined for both local and international markets. As part of GSK’s commitment to excellence, the company invests heavily in employee development, sustainability, and community engagement, making it an attractive destination for professionals seeking long‑term growth. This role is a cornerstone of GSK’s regulatory strategy, ensuring that all products meet stringent global standards while supporting the company’s mission of delivering safe and effective medicines to patients worldwide. By joining GSK, you become part of a diverse, inclusive, and forward‑thinking organization that values innovation, integrity, and impact, aligning perfectly with the growing demand for top talent in Mauritius Jobs.
Job Overview
The Regulatory Affairs Manager will lead GSK’s regulatory strategy for a portfolio of pharmaceutical products, overseeing submissions, approvals, and post‑marketing compliance across multiple jurisdictions. Reporting to the Head of Global Regulatory Affairs, you will collaborate with cross‑functional teams including R&D, Quality Assurance, Clinical Development, and Commercial Operations to ensure seamless product lifecycle management. This position plays a pivotal role in navigating complex regulatory landscapes, driving timely market access, and safeguarding product integrity. The role also involves mentoring junior regulatory staff, fostering a culture of continuous improvement, and representing GSK in interactions with health authorities. For more information about GSK’s commitment to career development, visit https://mauritiusjobsearch.com/. This opportunity is a prime example of Career Opportunities in Mauritius for seasoned professionals.
Key Responsibilities
- Develop and execute regulatory strategies for new product registrations and line extensions in target markets.
- Prepare, review, and submit dossiers (e.g., IND, NDA, MAA, CTD) to health authorities, ensuring accuracy and compliance.
- Maintain ongoing communication with regulatory agencies, addressing queries and facilitating inspections.
- Lead cross‑functional project teams to align regulatory requirements with product development timelines.
- Monitor changes in global regulatory policies and assess impact on GSK’s product portfolio.
- Provide regulatory guidance during clinical trial design, manufacturing scale‑up, and post‑marketing surveillance.
- Mentor and train junior regulatory staff, promoting best practices and knowledge sharing.
- Ensure all regulatory documentation is archived according to GSK’s quality management system.
Required Skills
- In‑depth knowledge of ICH guidelines, EMA, FDA, and local Mauritian regulatory frameworks.
- Strong analytical and problem‑solving abilities with attention to detail.
- Excellent written and verbal communication skills for drafting technical documents and interacting with authorities.
- Proven project management experience, capable of handling multiple concurrent dossiers.
- Leadership and team‑building skills to guide multidisciplinary teams.
- Proficiency with regulatory submission software (e.g., eCTD, Veeva Vault).
- Ability to work in a fast‑paced, matrixed environment while meeting strict deadlines.
Education
A Master’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Professional certifications such as RAC (Regulatory Affairs Certification) or equivalent are highly desirable and demonstrate a commitment to regulatory excellence.
Experience
Minimum of eight years of progressive experience in regulatory affairs within the pharmaceutical industry, including at least three years in a managerial or lead role. Experience with global submissions and a track record of successful product approvals are essential.
Salary
The compensation package ranges from SSP 900,000 to 1,200,000 annually, reflecting the seniority of the role, market benchmarks, and GSK’s competitive remuneration philosophy. Salary is complemented by performance‑based bonuses and comprehensive benefits.
Benefits
- Comprehensive health, dental, and vision insurance.
- Retirement savings plan with company matching contributions.
- Generous paid time off and parental leave policies.
- Employee assistance program and wellness initiatives.
- Professional development allowance and tuition reimbursement.
- Relocation assistance for eligible candidates.
Training
- On‑boarding program covering GSK’s regulatory processes and corporate culture.
- Access to internal and external regulatory training courses, workshops, and conferences.
- Leadership development tracks for high‑potential managers.
- Continuous learning platforms for up‑skilling in emerging regulatory trends.
Working Environment
GSK offers a collaborative, inclusive, and innovative workplace where diversity of thought is celebrated. The Goodlands campus features modern laboratories, flexible workspaces, and state‑of‑the‑art IT infrastructure, enabling employees to thrive. A strong emphasis on work‑life balance, sustainability, and community involvement makes GSK a preferred employer for those seeking meaningful Employment in Mauritius.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining 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 Goodlands facility.
Equal Opportunity Statement
GlaxoSmithKline (GSK) is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, race, religion, age, disability, sexual orientation, or any other protected characteristic. Our hiring practices reflect our dedication to fairness and the belief that diverse perspectives drive innovation and success.