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Associate Director/Director Regulatory Affairs, CMC

Cambridge, MA 02139

Post Date: 03/21/2018 Job ID: 1775 Job Category: Clinical: Regulatory

Our client is looking for an Associate Director/Director Regulatory Affairs, CMC. They will lead the CMC regulatory strategy and processes for assigned programs to significantly contribute in driving the development of our assets forward.

Job  Responsibilities:
  • Acting as the primary CMC regulatory representative on selected programs to develop CMC regulatory strategies, submissions and compliance activities
  • Managing CMC regulatory activities and timelines
  • Developing the strategy for meetings with regulatory authorities addressing necessary CMC requirements
  • Leading the planning and preparation of the CMC sections of global regulatory submissions
  • Collaborating with the greater CMC teams to provide regulatory guidance
  • Developing and maintaining regulatory knowledge of US, EU and ROW regulations
  • Performing literature searches, preparing special reports and assembling documentation to support project teams
  • Assisting in the development and maintenance of departmental processes, policies, SOPs and associated documents
  • Participating in initiatives aimed at improving internal departmental standards and systems

Qualifications/ Requirements:
  • Minimum of 8 years of experience in a biotech and/or pharmaceutical environment, including 4-5 years of Regulatory CMC experience
  • Minimum requirement of a Bachelor’ s Degree in a scientific discipline or equivalent
  • Experience with biologics program from development through registration
  • Experience in interacting and meeting with regulatory agency personnel on CMC related topics (e.g FDA, EMA etc.)
  • Experience in compiling and reviewing CMC sections of regulatory submissions (INDs, IMPDs, CTAs, BLAs, MAAs, etc.)
  • Knowledge of: drug development; FDA, EMA and ICH CMC guidelines and regulations; current Good Manufacturing Practices (cGMP)
  • You must be a team player that can handle multiple tasks simultaneously in a fast growing company
  • Possess outstanding verbal and written communication 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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