Life Sciences Regulatory & Compliance Associate

Title: CMC Delivery Lead, Mature Products (Vaccines) Location : Duration: 8–month contract – full-time

Apsida Life Science is currently partnering with a global clinical research company and technology-enabled Contract Research Organisation (CRO) that focuses on expanding access to clinical trials through a decentralised and community-integrated model.

Develop and implement CMC regulatory strategies for mature vaccine products to support global lifecycle maintenance.

Authoring & Review: Lead the authoring, technical review, and assembly of high-quality CMC documentation for variations and supplement submissions.

Health Authority Queries (HAQs): Coordinate and draft technical responses to CMC-related inquiries from global regulatory agencies to ensure timely approvals.

Compliance: Ensure all CMC activities adhere to established global regulatory guidelines and internal quality standards.

Partner with manufacturing, quality, and global regulatory teams to align on CMC priorities and project timelines

Strong background in Pharmaceutical Sciences, Biotechnology, or a related technical field.

Demonstrated ability to manage complex CMC projects within a global delivery model.

Excellent technical writing skills with a focus on precision and regulatory clarity.

Systems Knowledge: Proficiency with Veeva Vault or similar Regulatory Information Management Systems (RIMS) is preferred.

Ability to work effectively within the Indian time zone while supporting global stakeholders.

Proven experience in the CMC management of vaccines or biological products is mandatory.

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry.