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Associate Director, CMC Regulatory Affairs

Cambridge, Massachusetts 02142

Post Date: 02/15/2018 Job ID: 1771 Job Category: Clinical: Regulatory

Out client is seeking an Associate Director, Regulatory Affairs who will be responsible for CMC regulatory activities, strategies and submissions supporting the development and commercialization of current portfolio.

Job Responsibilities:
  • As a member of the program teams, provide strategic guidance on FDA and global regulatory requirements for clinical development and registration of small molecule pharmaceuticals.
  • Compile, review and approve CMC modules of development and marketing registration applications, amendments, and supplements for submission.
  • Development and implementation of CMC RA strategies for the earliest possible product approval and assistance with preparation for agency meetings.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Serve as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
  • Collaborate with contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.

Qualifications/ Requirements:
  • 5+ years of experience in Regulatory Affairs related to development of pharmaceuticals with a minimum of 4 years in Chemistry, Manufacturing and Control (CMC) regulatory environment, CNS experience preferred
  • Bachelor of Science in a scientific discipline (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred.
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and marketed products.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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