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Director, Regulatory Affairs CMC

Cambridge, MA

Posted: 10/07/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2658

Job Description


Our client is searching for a Director, Regulatory Affairs CMC to support programs in all phases of development and life-cycle management. This individual will be responsible for developing and implementing high-quality Regulatory CMC plans to enable continued compliance in multiple regions. The individual will have responsibility for managing CMC-related components of product development and commercialization (e.g., drug substance, drug product, packaging/distribution), as well as for representing Regulatory Affairs on CMC and Program teams and with partners. The individual will manage the preparation of high-quality CMC submissions to regulatory agencies. This position reports to the Vice President, Regulatory Affairs.

Responsibilities:
  • Lead the preparation of high-quality CMC sections for regulatory submissions including for INDs, IMPDs, the Japanese NDA (JNDA), US NDA, MAAs, and briefing packages
  • Manage and mentor Regulatory CMC direct reports as assigned
  • Write CMC regulatory documents to support regulatory submissions using industry best practices and internal standards
  • Propose and design well-informed global CMC regulatory strategies (US, EU, and Japan)
  • Represent Regulatory Affairs on CMC and Program teams and with partners
  • Provide regulatory guidance to the CMC department (e.g., stability protocols, specifications, report reviews, C of A’ s, product labels, and CMC development plans)
  • Collaborate with internal CMC staff, consultants, and QA colleagues, as well as external Contract Manufacturing Organizations (CMOs) to document and resolve technical manufacturing issues under compliance with cGMPs
  • Assist in the preparation for regulatory agency meetings on CMC topics
  • Maintain knowledge of global CMC regulatory requirements and advise internal stakeholders on emerging CMC regulatory trends
  • Coordinate on-time delivery of high-quality regulatory submissions to regulatory agencies
  • Establish relevant processes and procedures to support Regulatory Affairs function activities
  • Participate in regulatory intelligence gathering activities and maintain knowledge of global CMC regulatory requirements
  • Ensure compliance with all regulatory requirements

Requirements / Qualifications:
  • Bachelor' s degree required; Advanced degree in chemistry, biochemistry, or pharmacy preferred
  • 8+ years pharmaceutical industry experience with a minimum of 5 years in CMC Regulatory Affairs
  • Upward progression in role and leadership abilities. Leading teams or projects.
  • Experience managing and developing direct reports
  • Evidence of successful CMC submissions to FDA (e.g., INDs, briefing packages)
  • Demonstrated evidence of writing of CMC regulatory documents
  • Knowledge of FDA and ICH CMC regulations and guidelines a must, knowledge of EU and/or Japan CMC regulations desirable
  • Knowledge of drug development
  • Excellent written and oral communication skills
  • Excellent interpersonal skills
  • Strong project management skills and drive for excellence

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

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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