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Executive Director, Regulatory Strategy

Cambridge, Massachusetts

Post Date: 10/12/2017 Job ID: 1703 Job Category: Clinical: Regulatory

Our client is seeking an Executive Director, Regulatory Strategy. Reporting into the Sr. Vice President, Regulatory Affairs, the Executive Director, Regulatory Strategy is responsible for developing and directing regulatory strategy, objectives, policies and programs pertaining to the development and marketing of assigned products. This role includes the regulatory responsibility to support the US and global registration and life cycle management. The qualified candidate will serve as the US and global regulatory strategy lead for assigned projects.   This is both a strategic and hands-on tactical role within the Global Regulatory Affairs team. 

Job Responsibilities:
  • Responsible for providing innovative and proactive strategic leadership to project teams in early and late stage clinical programs
  • Lead the planning, strategy content and execution of NDA/BLA filings and approval
  • Proactively identify regulatory risks to the strategic and operational/tactical plans and propose options to mitigate risks
  • Prepare and lead the team in negotiations with FDA on assigned products as needed
  • Lead and supervise the planning and preparation (including authoring where appropriate) of routine and complex documents, including INDs, briefing documents, orphan drug designation, fast track and rare pediatric designation as appropriate
  • Provide regulatory due diligence as needed
  • Work closely with Alliance partners to prepare and execute global regulatory development partners
  • Provide client with current and proposed regulatory, scientific and  pertinent legal issues (i.e., external meetings, workshops and conferences).
  • Ensure that all documents to be submitted to regulatory agencies have  been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.
  • Guide project teams to implement appropriate regulatory strategies.
  • May train or mentor junior staff


Qualifications/ Requirements: 
  • 10+ years of pharmaceutical/biotechnology industry experience with technical management experience
  • Minimum of 5 years of experience in US and/or the EU as a Regulatory Lead
  • Proven track record of successfully leading NDA/BLA or MAA submissions
  • Ability to successfully interact with all levels of management
  • Demonstrated knowledge of drug development process in the US and/or the EU is essential. Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience.
  • Must have prior experience working with FDA and/or EMA.
  • Ability to analyze and interpret scientific and technical information, as well as regulatory documents
  • Experience of successful NDA and/or BLA filing essential.
  • B.A./B.S. or higher degree (s) in the sciences, or health related field. Advanced scientific degree preferred
  • Demonstrates personal leadership and be excellent mentors, with a natural ability to bring divergent views together, agree common objectives
  • Experience in gene therapy a plus

 

Aaron Goldman
Clinical Recruiter

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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