- Coordinate with API manufacturers, suppliers, and vendors to obtain regulatory and technical documentation, including DMFs, CoAs, MoAs, GMP certificates, specifications, and stability data.
- Maintain and track project-wise regulatory documentation, including pending and received documents.
- Follow up with vendors regarding regulatory queries, documentation deficiencies, and pending requirements.
- Coordinate with the India and Russia Regulatory Affairs teams to ensure timely submission of required documents.
- Maintain proper records of regulatory correspondence and escalate delays wherever necessary.
Candidate Requirements:
- 2–3 years of experience in Regulatory Affairs, regulatory documentation, or pharmaceutical compliance coordination.
- Experience working with API manufacturers and pharmaceutical suppliers will be preferred.
- Solid vendor coordination, documentation management, and follow-up skills.
- Good written and verbal English communication skills.
- Ability to manage multiple projects and coordinate with international teams.