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Principal Consultant (CMC – Biologics)
A leading global regulatory consultancy is seeking a Principal Consultant (CMC – Biologics) to join its fast-growing team. This senior, full-time role offers the opportunity to provide strategic regulatory and technical guidance to global clients while mentoring junior staff and shaping product development strategies across biologics and advanced therapies.
Key Responsibilities
- Deliver strategic and technical CMC regulatory advice for global drug development programs
- Author and review regulatory documents (INDs, IMPDs, MAAs, BLAs, etc.)
- Lead client engagements and represent them during regulatory interactions
- Oversee project budgets and timelines, ensuring high-quality service delivery
Requirements
- PhD/MSc/BSc in a life or physical science discipline
- 10+ years’ experience in CMC development and regulatory affairs
- Expertise with biologics, including recombinant proteins, antibodies, vaccines, biosimilars, and ATMPs
- Deep knowledge of FDA, EMA, ICH, and TGA regulatory guidelines
- Experience in authoring major submissions and representing clients before regulators
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