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Director, Regulatory Affairs

Cambridge, Massachusetts 02139

Post Date: 03/23/2018 Job ID: 1911 Job Category: Clinical: Regulatory

Our client is seeking a Director, Regulatory Affairs to lead the preparation of regulatory submissions to assure full compliance with all relevant requirements in the U.S. as well as in Europe, Canada, Japan and Australia.

Responsibilities:
  • Provide strategic and operational input, guidance and oversight to global project teams to assure that regulatory submissions and all aspects of regulatory compliance support R&D objectives.
  • Develop and create regulatory compliance strategies for multiple clinical development projects.
  • Coordinate all aspects of the preparation, review and submission of regulatory documents.  This includes the clinical and non-clinical portions of documents.
  • Represent the Regulatory Affairs Department as a member of cross functional project teams and provide guidance relating to changing global regulatory requirements.
  • Serve as the Company’ s Regulatory Affairs Lead in interactions with global health authorities including the FDA, EMA, MHRA, Health Canada and ROW with respect to clinical submission documents.
  • Provide leadership and direction in the development of clinical regulatory documents including INDs, CTAs, BLAs, DMFs, NDAs and MAAs.
  • Make submissions to global regulatory authorities, as required, and maintain an ongoing interactive relationship regarding these submissions.
  • Coordinate and maintain reporting schedules for regulatory applications.
  • Assure that all aspects of the Company’ s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
  • Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning.
  • Identify and communicate to executive management information about potential regulatory issues; propose risk evaluations and mitigation strategies.
  • Mentor and help develop the strategic & technical expertise of regulatory colleagues who are involved in supporting filings.

Requirements:
  • Bachelor’ s degree in a relevant scientific discipline.  Master’ s or an advanced degree (PhD, PharmD) is preferred.
  • 15+ years of regulatory affairs experience in the pharmaceutical industry.
  • Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements.
  • Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC).  Experience with regulatory filings in oncology is preferred.
  • Strong written and oral communication skills and the ability to interact effectively with project teams.
  • Ability to manage regulatory affairs activities and provide leadership in a “ hands-on fashion” while utilizing a strategic approach in all aspects of global compliance.

Demeika Roberts

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