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:

+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