CMC Strategy Lead

6 days ago


London, Greater London, United Kingdom Barrington James Full time

Barrington James is seeking a seasoned regulatory expert to spearhead our CMC strategy initiatives. As a CMC Strategy Lead, you will be responsible for developing and executing innovative regulatory strategies that drive success in the pharmaceutical industry.

Key Responsibilities:
  1. Design and implement comprehensive CMC regulatory plans
  2. Prepare and review critical regulatory documents, such as INDs, IMPDs, and MAAs
  3. Collaborate with regulatory agencies, ensuring effective communication and negotiation
  4. Manage project timelines, budgets, and deliverables, fostering a culture of excellence
  5. Provide guidance and mentorship to team members, promoting growth and development
  6. Pursue business opportunities, building strong relationships with clients
  7. Stay abreast of regulatory developments, ensuring compliance with evolving standards

Essential Qualifications:

  • At least 8 years of experience in drug development and regulatory affairs
  • Demonstrated expertise in FDA, EMA, and/or MHRA processes
  • Proven track record in biologics, ATMPs, vaccines, or small molecules
  • Advanced degree in life sciences (MSc or PhD preferred)
  • Exceptional leadership, organizational, and time management skills

Salary: £100,000 - £120,000 per annum.


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