Global Regulatory Affairs Lead: Product Compliance

About the Role

Assist the Regulatory Affairs (RA) team in executing various regulatory functions aimed at meeting departmental goals. The role involves global product registration, lifecycle management, document preparation, and coordination with regulatory bodies and internal teams.

• Manage global product registration processes for different markets.

• Oversee the lifecycle management of approved products, ensuring continued compliance.

• Compile and update regulatory dossiers for Rest of World (ROW) markets.

• Gather and review Chemistry, Manufacturing & Controls (CMC) data required for dossier compilation.

• Prepare and organize documents for variation applications as needed.

• Collaborate on responses to queries from global Regulatory Authorities.

• Coordinate with internal teams to obtain necessary documents and arrange product samples.

• Draft and complete Product Questionnaires.

• Prepare and review Draft Artwork, Summary of Product Characteristics (SMPC), and Patient Information Leaflets (PIL) according to country-specific regulations and client specifications.

• Stay informed on new and draft regulations, guidelines, and post-approval requirements from global regulatory bodies.

• Prepare applications for legal documents, including Product Approvals, Certificate of Pharmaceutical Product (CoPP), Free Sale Certificate (FSC), and renewal of WHO GMP and Manufacturing Licenses.

• Keep the Market Authorization database and RA workplan regularly updated with accurate regulatory data.

• Possess strong listening and communication skills for effective internal and external coordination.

4–5 years of experience in regulatory affairs, preferably in pharmaceutical or healthcare sectors.