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CMC Regulatory Strategy Lead

3 weeks ago

Princeton, New Jersey, United States Lynkx Staffing LLC Full time

Are you a seasoned professional looking for a new challenge? We are seeking a highly skilled Regulatory Affairs Chemistry Manufacturing & Controls Director to join our team at Lynkx Staffing LLC. In this role, you will develop and execute regulatory strategies for CMC components, oversee all RA-CMC operations, and mentor junior colleagues in lifecycle regulatory-CMC and eCTD strategy.

Key Responsibilities:
  • Regulatory Strategy Development: Plan, prepare, and critically review CMC components of regulatory documents, including INDs, Annual Reports/DSURs, Amendments, and more.
  • Operational Leadership: Lead all RA-CMC operations through all phases of clinical development, from FIH through post-approval maintenance.
  • Mentorship and Process Improvement: Provide guidance and support to junior colleagues, participate in process improvement initiatives, and back up the Head of Regulatory CMC as needed.

To be successful in this role, you will need a Master's degree with 15+ years of experience in the pharmaceutical or biopharmaceutical industry. You should possess strong knowledge of CMC regulatory affairs, excellent leadership and collaboration skills, and the ability to work in a fast-paced environment.