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Associate Director, Regulatory Affairs

Cambridge, Massachusetts 02142

Post Date: 03/07/2018 Job ID: 1889 Job Category: Clinical: Regulatory

  • Develop regulatory strategy and submission plans for quality and timely filings.
  • Provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.
  • Oversee preparation, review, and submission of regulatory documents maintaining compliance with regulatory requirements.
  • Prepare regulatory agency meeting requests and briefing documents.
  • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Support the organization and record regulatory meetings with health authorities.
  • Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
  • Provide support for regulatory review of publications and clinical trial materials
  • Manage contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.
  • Assist with SOP generation.
  • Perform other duties as required, interfacing with other departments, CROs and external vendors as needed

Experience, Education and Specialized Knowledge and Skills
  • At least 8+ years of experience in Regulatory Affairs related development of pharmaceuticals; preference for experience with small molecule development (Phase 1 through NDA and post-approval)
  • Bachelor of Science in a scientific discipline, Masters preferred
  • 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.
  • Strong regulatory writing skills and knowledge of eCTD elements and structure

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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