🚀 Principal Lead/ Director (CMC) – Small Molecule Development (Level dependent on candidate seniority)
📍 UK Hybrid - 1 day per week on site
I'm currently supporting a growing international regulatory and product development consultancy that is looking to appoint a Principal Lead/ Director (CMC) to join its expanding team.
This is a strategic, client-facing position focused on supporting pharmaceutical and biotech companies with small molecule drug development, providing expert CMC and regulatory guidance from early development through to marketing authorisation and lifecycle management.
Key requirements:
✔ Extensive experience in CMC development within the pharmaceutical industry
✔ Strong expertise in small molecule drug development
✔ Proven experience across the full product lifecycle, including development, manufacturing, scale-up, regulatory submissions, and post-approval activities
✔ Strong knowledge of FDA, EMA, ICH, and GMP requirements
✔ Experience authoring and reviewing regulatory submissions including INDs, CTAs, IMPDs, MAAs, NDAs, and DMFs
✔ Background in pharmaceutical development, manufacturing, technical transfer, process development, or CMC strategy
✔ Leadership experience, including mentoring and supporting more junior colleagues
✔ Strong stakeholder management and client-facing consulting skills
This opportunity offers the chance to work on a diverse range of global development programmes, influence regulatory and development strategies, and play a key role in the growth of a highly regarded consultancy.
📩 If you have a strong CMC background and would be open to hearing more, please get in touch for a confidential discussion.
Tshering Sherpa
