Director Regulatory Affairs Chemistry Manufacturing

7 days ago

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

Lynkx Staffing LLC is seeking a seasoned Director Regulatory Affairs Chemistry Manufacturing & Controls to lead global teams through the development and execution of regulatory strategy and the design of CMC components of drug development programs.

Key Responsibilities
  • Plan, prepare, and critically review CMC components of regulatory documents including INDs, Annual Reports/DSURs, Amendments, Comparability Protocols and Evaluation Packages, BLAs, NDAs, DMFs, Meeting Briefing Packages, SPA, IBs, and equivalent documents of other countries' health authorities without supervision.
  • Lead all RA-CMC operations through all phases of clinical development; from FIH through post-approval maintenance.
  • Communicate and collaborate with global counterparts effectively, ensuring alignment.
  • Mentor lower-level members in RA and RA-CMC in lifecycle regulatory-CMC and eCTD strategy.
  • Lead and/or participate in process improvement initiatives between business entities.
  • Lead the CMC aspects of Health Authority meetings.
  • Responsible as a back up to the Head of Regulatory CMC.
Requirements
  • MS Degree required with 15+ years of related experience in the pharmaceutical or biopharmaceutical industry.
  • Up-to-date knowledge of both existing and emerging regulatory guidance and sciences related to CMC.
  • Good working knowledge of Microsoft Office required.
  • Prior experience with authoring, submission, and approval process of a major marketing application.
  • Prior experience with assessing change controls and the preparation of post-approval supplements.
  • Experience with primary authoring of all drug substance and drug product sections.
  • Cultural sensitivity is essential and the ability to develop consensus within a multinational organization necessary.
  • Broad level of interpersonal skills, leadership ability and flexibility also necessary.
  • Excellent collaboration skills needed.
  • Excellent problem-solving skills also needed.

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