Regulatory Affairs CMC Specialist/Sr. Specialist (Remote)

NWRPros Remote
regulatory cmc remote cmc regulatory regulatory requirements health ich guidelines director project teams commercial applications procedures content
May 14, 2022
NWRPros
Seattle, WA
This position is primarily responsible for coordinating the preparation, review, and compilation of CMC filings in support of commercial applications in accordance with ICH requirements, regional requirements, and scientific and company policies and procedures.



Position Responsibilities:

  • Creates/compiles content of CMC documentation to regulatory agencies (NDA/MAA), setting the standards for CMC regulatory submissions to assure adequacy, completeness, and accuracy

  • Coordinates the preparation of CMC submissions through editing and approval of final documents including review for quality in a timely manner

  • Leads compilation of background information and preparations for CMC meetings with health authorities

  • Has a solid understanding of CMC regulatory requirements including FDA and ICH guidelines and relevant government regulations as they apply to post approval changes to marketed products as well as the registration, development and approval of investigational products

  • Researches up-to-date knowledge of regulatory requirements and communicates changes in regulatory information to director and project teams in a timely manner

  • Maintains current awareness of evolving health authority interpretations; including advisory letters, enforcement letters and policy issues.  Communicates significant changes or other relevant matters to director and project teams in a timely manner

  • Leads local and/or global submission process to assist in the overall efficiency of the regulatory submission process

  • Manages regulatory CMC activities within time and budget for approved project plans


Education, Experience, Skills, and Knowledge Required:


  • College degree, preferably in Chemistry or other scientific discipline, plus training and experience in regulatory affairs CMC

  • 5 years or greater experience in the pharmaceutical industry with a minimum of 3 years of experience in regulatory CMC

  • Solid understanding of CMC regulatory requirements (FDA and ICH guidelines)

  • Prior expereince primarily supporting large molecule/biologics and working knowledge of monoclonial antibodies

  • Computer application skills: Advanced MS Office, Adobe Acrobat skills

  • Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines

  • Good oral and writing skills, strong work ethic


Behavioral Competencies Required: 


  • Ability to build and maintain positive relationships with management, peers, subordinates, and external clients.


Display strong analytical and problem‑solving skills

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