Role: Biologics Consultant
Location: India (Remote)
Employment Type: Contract
Duration: 8-12 Months
Workload: 0.8 FTE
Company Overview:
Apsida Life Science has partnered with a leading global clinical research organisation (CRO) that designs and delivers clinical trials with the patient in mind. Our partner defines itself by the difference it makes in patients’ lives and the compassion it brings to every aspect of its work.
The Opportunity:
- Extensive expertise within Biologics or Vaccines.
- CMC Strategy & Execution: Lead the CMC regulatory strategy for mature vaccine products, ensuring all Life Cycle Management (LCM) activities align with global health authority requirements.
- Draft, compile, and review high-quality CMC dossiers and variations (Modules 2.3 and 3) for global submissions.
- Manage submissions for a diverse portfolio across major (US/EU/Canada) and emerging markets.
- Lead the preparation of robust, scientifically sound responses to Health Authority Queries to ensure timely approvals.
- Coordinate with cross-functional teams in Manufacturing, Quality, and Regulatory Affairs to gather technical data and ensure documentation accuracy.
What You Need:
- 5+ years proven track record in CMC Regulatory Affairs, specifically focused on Biologics or Vaccines (Mandatory).
- Extensive experience in CMC strategy and authoring for mature products/post-approval changes.
- Deep understanding of regulatory landscapes in the US (FDA), EU (EMA), Canada (Health Canada), and RoW markets.
- Health Authority Interaction: Demonstrated experience managing and responding to HAQs.
If you are interested in learning more, please reach out to Linda Goba at Apsida Life Science
Email: Linda.goba@apsida.com
Website: www.apsida.co.uk
Phone: +44 (0) 744 134 2145
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, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.
Website: www.apsida.co.uk
…