Regulatory Affairs Manager

Role & responsibilities 1. Regulatory Strategy and Compliance 2. Review, and submit regulatory dossiers for product approval and market authorization in compliance with regulatory standards. 3. Coordinate and lead responses to regulatory authorities' queries, ensuring timely and accurate replies. 4. Monitor changes in regulatory guidelines, industry standards, and market conditions, and assess their impact on the organizations products and regulatory strategy. 5. Advise internal teams (R&D, manufacturing, labelling, clinical, etc.) on regulatory requirements related to product development, manufacturing, and advertising. 6. Assist in the preparation and submission of updates, renewals, amendments, and variations in accordance with product lifecycle management. 7. Stakeholder Engagement 8. Cross-functional Collaboration.

Preferred candidate profile M. Pharma (Pharmacy)

Perks and benefits