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Associate Director, CMC Regulatory Affairs

Cambridge, Massachusetts

Post Date: 10/12/2017 Job ID: 1698 Job Category: Clinical: Regulatory

Our client is looking for an Associate Director of CMC Regulatory Affairs to join their growing and dynamic team.  Reporting to the Director of Regulatory Affairs, the Associate Director of CMC Regulatory Affairs will be the leader in interactions with the Regulatory Authorities as necessary to support CMC activities.  The person in this position will guide CMC regulatory strategy to support global development of small molecules and will be responsible for the development of compliant, high quality, CMC related submissions to support early development, registration and life cycle management.

Job Responsibilities:
  • Plan, write and review CMC sections across all pertinent regulatory submissions (i.e. clinical trial and marketing applications, formal meetings, life-cycle management submissions)
  • Develop and execute CMC regulatory strategy for long-term planning including the potential to accommodate expedited development needs
  • Work effectively and provide regulatory expertise to cross-functional teams
  • Review and approve technical documentation in support of CMC and QA activities for small drug molecule programs and to assess regulatory impact for development process changes
  • Engage with Regulatory Authorities on project related matters
  • Provide insight and guidance on implementation of current regulations with respect to the preparation and submission of CMC regulatory documentation as a member of internal Project Teams


Qualifications/Requirements:
  • B.S. in a scientific discipline required (degree in Chemistry strongly preferred); advanced degree a plus
  • Must have 8-10+ years pharmaceutical industry experience in CMC Regulatory Affairs
  • Solid knowledge of: drug development; FDA, EMA and ICH CMC guidelines and regulations; current Good Manufacturing Practices (cGMP)
  • Experience with small molecule drug development is required
  • Previous direct experience with early development programs through registration strongly preferred
  • Excellent organizational and communication skills, both written and verbal
  • Must have previous experience leading interactions with health authorities

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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