Job Details

  • Title: Regulatory CMC Manager
  • Code: RCI-35869-1
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 02/25/2021
  • Duration: 6 Months
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  Job Description

  • Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
  • Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
  • Responsible for the global regulatory evaluation of CMC change controls with supervision.
  • Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
  • Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
  • Participate in global regulatory interactions with health authorities, with supervision.
  • Facilitate document review meetings and discussions.
  • Develop and maintain knowledge of regulatory environment, regulations and procedures.
Skills/Knowledge Required:
  • BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience
  • Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
  • Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
  • Experience in drug development processes and post-approval requirements
  • Experience in developing CMC regulatory strategy
  • Experience in project management
  • Have a solution-oriented approach to problem solving
  • Ability to plan/prioritize work of group members and guide/develop others.
  • Ability to work on complex projects and within cross-functional teams with supervision
  • Excellent communication skills, both written and oral