Regulatory Affairs Director

13 hours ago


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

Lynkx Staffing LLC is seeking a highly experienced Director Regulatory Affairs Chemistry Manufacturing & Controls (CMC) to lead global teams in developing and executing regulatory strategies for pharmaceutical clients.

  • Develop and implement regulatory strategies for CMC components of drug development programs, collaborating with project teams and health authorities.
  • Lead RA-CMC operations through all phases of clinical development, from FIH to post-approval maintenance.
  • Mentor lower-level team members in RA and RA-CMC lifecycle regulatory-CMC and eCTD strategy.
  • Collaborate with global counterparts to ensure alignment and effective communication.

Requirements

  • MS Degree with 15+ years of experience in pharmaceutical or biopharmaceutical industry.
  • Up-to-date knowledge of regulatory guidance and sciences related to CMC.
  • Excellent collaboration and leadership skills.
  • Cultural sensitivity and ability to develop consensus within a multinational organization.


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