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Associate Director, Regulatory Affairs CMC

Cambridge, MA

Posted: 10/14/2020 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2659

Job Description


Our client is currently expanding its Regulatory team to support late-phase clinical assets and is searching for an Associate Director, Regulatory Affairs to support the continued development of our client’ s therapy in the treatment of anemia. This individual will operate in a high-visibility role and will be responsible for developing and coordinating regulatory strategies and leading NDA/MAA preparation and submission to regulatory agencies. In this position, they will partner with the Clinical, Medical, Program Management and Alliance Management groups to move this work forward.

Responsibilities:
  • Design and support implementation of well-informed global regulatory strategies
  • Represent Regulatory Affairs project sub-teams and provide regulatory guidance (e.g., protocol reviews, report reviews, development plans)
  • Support and lead in the preparation of meetings with Regulatory Health Authorities (e.g. U.S., E.U)
  • Lead in the coordination, preparation and timely submission of regulatory documents (e.g. INDs, MAAs, NDAs).
  • Manage regulatory aspects of Phase 3 and other clinical trials concurrently
  • Manage, mentor, and develop direct reports
  • Write regulatory documents to support regulatory agency submissions
  • Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
  • Establish relevant processes and procedures to support the Regulatory Affairs function activities
  • Participate in regulatory intelligence gathering activities and maintain knowledge of US, EU and ROW regulatory requirements
  • Ensure compliance with regulatory requirements

Requirements / Qualifications:
  • Bachelor' s degree; Advanced degree in chemistry, biochemistry, or pharmacy preferred
  • 6+ years pharmaceutical industry experience with a minimum of 4 years in CMC Regulatory Affairs
  • Upward progression in role and leadership abilities.
  • Experience 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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