Job Description
Position: Regulatory Affairs Manager
Company: Novartis
Location: Vacoas-Phoenix, Mauritius
Experience: 5-7 years in regulatory affairs within pharmaceutical industry
Education: Master’s degree in Pharmacy, Life Sciences or related field
Employment Type: Full-time
Industry: Pharmaceuticals
Department: Regulatory Affairs
Salary: SSP 900,000 – SSP 1,200,000 per annum
Vacancies:1
Company Overview
Novartis is a globally recognized leader in innovative medicines, vaccines, and consumer health products. With a strong commitment to improving health outcomes, Novartis operates in more than 150 countries and maintains a robust research and development pipeline. In Mauritius, Novartis has established a regional hub that supports regulatory, clinical, and commercial activities across the African continent. The company’s presence in Vacoas-Phoenix reflects its strategic focus on expanding access to high‑quality pharmaceuticals while fostering local talent and contributing to the nation’s economic growth. This role offers a unique opportunity to be part of a world‑class organization that values scientific excellence, ethical standards, and sustainable development.
Job Overview
The Regulatory Affairs Manager will lead the preparation, submission, and maintenance of product dossiers for medicines marketed or under development in Mauritius and the broader African region. Reporting to the Head of Regulatory Affairs, the incumbent will ensure compliance with the Mauritius Medicines Authority (MMA) and international regulatory frameworks such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This position is critical for accelerating product launches, safeguarding patient safety, and supporting Novartis’s mission of delivering innovative therapies. The role directly contributes to the company’s growth strategy and aligns with the increasing demand for skilled professionals in the pharmaceutical sector, making it a prime Career Opportunities in Mauritius for ambitious regulators.
https://mauritiusjobsearch.com
Key Responsibilities
- Lead the preparation, review, and submission of marketing authorisation applications, variations, renewals, and post‑approval changes.
- Maintain a comprehensive regulatory intelligence database to monitor changes in local and international legislation.
- Collaborate with cross‑functional teams including Clinical Development, Quality Assurance, and Commercial to ensure alignment on regulatory strategies.
- Act as the primary liaison with the Mauritius Medicines Authority and other regulatory bodies, managing queries and inspections.
- Develop and implement regulatory risk mitigation plans for all product portfolios.
- Provide regulatory guidance and training to internal stakeholders to promote compliance culture.
- Prepare and review labeling, packaging, and promotional materials for regulatory compliance.
- Support the development of regulatory dossiers for new product introductions and lifecycle management.
Required Skills
- In‑depth knowledge of Mauritian pharmaceutical regulations and international guidelines (ICH, EMA, FDA).
- Strong analytical and problem‑solving abilities with attention to detail.
- Excellent written and verbal communication skills in English; French proficiency is an advantage.
- Proven project management experience, capable of handling multiple dossiers simultaneously.
- Ability to work collaboratively in a multicultural, matrixed environment.
- Proficiency with regulatory submission software and document management systems.
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.
Experience
Candidates must have a minimum of five to seven years of progressive experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to both local and global submissions. Experience in managing submissions to the Mauritius Medicines Authority and familiarity with African regional regulatory networks will be considered a strong asset.
Salary
The competitive salary range for this position is SSP 900,000 to SSP 1,200,000 per annum, commensurate with experience and qualifications. The package includes performance‑based bonuses and a comprehensive benefits scheme.
Benefits
- Health insurance covering medical, dental, and vision care.
- Retirement savings plan with employer contributions.
- Generous paid time off and statutory holidays.
- Employee assistance program and wellness initiatives.
- Professional development allowance and support for certifications.
Training
- Onboarding program covering Novartis’s regulatory processes and corporate culture.
- Continuous learning opportunities through internal e‑learning platforms and external workshops.
- Mentorship from senior regulatory leaders across global sites.
Working Environment
Novartis offers a dynamic, inclusive, and collaborative workplace where innovation thrives. The Vacoas‑Phoenix office provides modern facilities, flexible working arrangements, and a supportive community that encourages knowledge sharing and career growth. Employees benefit from a culture that values diversity, ethical conduct, and work‑life balance.
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. For more information about the role and to apply, please visit the official job posting page.
https://www.mauritiusjobsearch.com/
Equal Opportunity Statement
Novartis 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, colour, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.