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AD/Director, Regulatory Affairs CMC

Cambridge, Massachusetts 02142

Post Date: 03/15/2018 Job ID: 1701 Job Category: Clinical: Regulatory

Director, Regulatory CMC Affairs

Reporting to the Senior Director of Regulatory CMC, this position will provide support for Chemistry Manufacturing and Controls (CMC RA) for development and marketed products. This position will provide product strategy and direction to commercial and clinical teams. Incumbent will be responsible for assuring the regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality. Experience working in a matrix environment and excellent people skills are required.

  • As a member of the project teams, provide strategic CMC regulatory guidance for global development and registration programs (eg. INDs, CTAs, NDAs and MAAs)
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
  • Primary regulatory representative (for assigned projects) at internal meetings as well as at meetings with regulatory agencies for all CMC related issues
  • Compile, review, approve and submit CMC and marketing registration applications, supplements and variations. Writing appropriate section of the Module 3 and 2(relevant sections only) and responding to regulatory questions from various regulatory authorities, working in collaboration with SME’ s in Tech Ops, QC/QA, global supply chain and other business partners .
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Manage contract staff and vendors as needed to support regulatory activities.


  • Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 10- 15 years regulatory experience.
  • Experience of successful INDs, NDA and/or BLA filing(s) is essential
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and marketed products.
  • First-hand knowledge and experience of FDA CMC regulatory submissions is essential
  • Strong knowledge of eCTD elements and structure and regulatory writing skills
  • Possesses strong written and verbal communication and presentation skills.
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Strong team player that has a customer service approach and is solution oriented.


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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