Fusion De Nova is a fast-growing merchant exporter of high-quality pharmaceutical products from India, serving diverse international markets across Africa and Latin America including the Dominican Republic, Honduras, Guatemala, and El Salvador. As we expand our global footprint, we are looking for an experienced professional to lead our Regulatory Affairs Department and strengthen our compliance operations across all export destinations.
Key Responsibilities- Lead and oversee all regulatory affairs activities for global markets (Africa & LATAM).
- Prepare, compile, and review export registration dossiers as per country-specific requirements.
- Liaise with international regulatory authorities, agents, and clients to ensure timely product approvals.
- Stay updated on global regulatory guidelines, WHO, and country-specific MOH requirements.
- Coordinate with internal departments (QC, QA, Purchase, and Export teams) to maintain compliance.
- Strategize and implement regulatory submission plans for new product launches and renewals.
- Represent the company in audits, reviews, and compliance meetings with global partners.
Desired Candidate Profile- Qualification: M.Pharm / B.Pharm / Life Sciences graduate with strong regulatory expertise.
- Experience: Minimum 812 years in Regulatory Affairs within the pharmaceutical export sector.
- Demonstrated experience handling African and Latin American markets (CARICOM, PAHO regulations preferred).
- Strong understanding of dossier compilation (CTD/ACTD), product registration, and export documentation.
- Excellent communication skills and adaptability to multicultural markets.
- Leadership ability to head and expand the Regulatory Affairs team.
Why Join Us- Opportunity to lead a core compliance function in a rapidly expanding export organization.
- Exposure to diverse international markets and world-class regulatory practices.
- Collaborative work environment in a dynamic team based in Chennai.
Interested candidates can apply via LinkedIn or share their profiles at [[Confidential Information]] with the subject line: Application Manager / Head (Regulatory Affairs).
