Director, Global Regulatory Lead

Precision Life Sciences - Cambridge, MA

We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for high-impact projects while working with decision-makers across multiple functional areas.

Responsibilities

As a Director, Global Regulatory Lead, on one or more projects you will:

  • Serve as a member of the Global Project Team (GPT) utilizing precedent and experience to develop innovative and flexible approaches to achieve development goals, advise on development strategies, and deliver on associated regulatory activities,
  • Lead the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality regulatory deliverables to the GPTs,
  • Lead health authority interactions, including leading the team through the creation of briefing materials and meeting preparation,
  • Lead and/or support global filing activities for submissions,
  • Present regulatory strategies including communication of regulatory risks and associated mitigation plan to management and other internal stakeholders,
  • Perform or supervise the regulatory review of all clinical and non-clinical documents for submissions, e.g., clinical protocols and study reports, preclinical reports, investigator brochures, application summary documents, etc.,
  • Research and analyze the evolving competitive and regulatory landscapes to maintain current knowledge, and effectively manage timelines while working in a fast-paced and dynamic environment across both time zones and cultures.

Qualifications

  • A Bachelor’s degree in a scientific discipline is required/an advanced degree is strongly preferred
  • Minimum of 10 years of drug development/FDA/regulatory-related industry experience required
  • Demonstrated knowledge of global regulatory requirements for drugs and biologics
  • Proven ability to develop robust regulatory strategies required
  • Experience interacting directly with regulatory authorities on an international scale,
  • Experience preparing teams for and leading meetings with regulatory agencies, including the FDA
  • Experience with rare disease drug development, innovative trial design, and/or expedited regulatory pathways, highly desired,
  • Experience in setting direction for, leading, and motivating a team to work for joint objectives,
  • Excellent verbal and written communication skills,
  • Strong organizational and demonstrated problem-solving capabilities
  • Ability to thrive in a busy environment and maintain a positive attitude under pressure.


Posted On: Wednesday, July 20, 2022



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