Title:CMC Delivery Lead, Mature Products (Vaccines)
Location: India
Duration: 8–month contract – full-time
Company Overview
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.
Key Responsibilities
- CMC Strategy & Execution: 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.
- Global Market Support: Manage submissions for a diverse range of health authorities, including the US (FDA), EU (EMA), Canada (Health Canada), and Rest of World (RoW) markets.
- 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.
- Stakeholder Collaboration: Partner with manufacturing, quality, and global regulatory teams to align on CMC priorities and project timelines
Qualifications
- 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.
- Vaccines/Biologics: Proven experience in the CMC management of vaccines or biological products is mandatory.
If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:
[Confidential Information]
+44 7441 342281
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. We believe there is a gap in the market for a cost effective, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process
