Head of Regulatory Affairs, North America

This pre-IPO biopharmaceutical company is developing treatments for some of the most common illnesses in the world where current therapeutics are insufficient or nonexistent.  They are seeking a Head of Regulatory Affairs, North America who can develop, lead and execute on all regulatory strategies for their pipeline programs in the US, while partnering with colleagues on global filings.  You will build out the US regulatory function while working directly with the FDA. This position can be located in either their Durham, NC office or their SF Bay Area R&D Center. This company offers a patient-first culture along with pre-IPO equity. Now is an exciting time to join this growing organization and help to get breakthrough therapies approved! 

Responsibilities:

  • Provide strategic and tactical leadership of the regulatory affairs function in North America, in close collaboration with cross functional teams.
  • Lead FDA interactions and submissions to achieve successful approvals of clinical trials and marketing applications.
  • Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.
  • In collaboration with regulatory colleagues in China, devise and implement global regulatory strategy and provide leadership oversight for regulatory submissions.
  • Oversight of commercial regulatory activities across the lifecycle of products for responsible territories.
  • Foster strong relationships and advocacy with FDA as well as other international regulatory authorities.
  • Manage, oversee and/or prepare regulatory documents and submissions in accordance with business strategies.
  • Direct the strategy for Health Authority engagements including the request, preparation and execution of meetings and correspondences with regulatory authorities for product-specific and policy-related issues.
  • Collaborate with internal and external (CRO) staff to author and compile documents for submission to regulatory agencies, including INDs, CTAs, BLAs, MAAs, and NDAs.
  • Ensure corporate compliance for manufacturing licenses, government reporting requirements, etc.
  • Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies changes on company pipeline strategy.
  • Keep management informed of regulatory status of products and significant regulatory issues.
  • Develop and design robust regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into future direction.
  • Hire, develop and mentor regulatory personnel and future regulatory staff.
  • Represent regulatory with internal and external partners.
  • Provide guidance to business development regarding critical evaluation of potential product opportunities supporting strategic partnering and licensing activities.

 Qualifications:

  • Bachelor’s degree in a scientific field. Advanced degree, such as PharmD, PhD, MS preferred.
  • Ten or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
  • Must have experience leading and managing Regulatory teams or direct reports.
  • Experience developing and leading regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs with a track record of successful approvals.
  • Direct experience working with the FDA and other health authorities. Global experience highly desired.
  • Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
  • Therapeutic area experience in infectious disease or CNS programs is preferred but not required.
  • In-depth understanding of the drug development, product commercialization and life cycle management processes combined with experience in Quality Assurance, Development, Clinical and Compliance is desired.
  • Experience and/or active involvement in co-development partnership and in/out-licensing business opportunities is a plus.
  • Must be able assimilate and interpret trends in the US healthcare regulatory environment that directly affect business decisions in the pharmaceutical and biotech industry
  • Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups
  • Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards
  • Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details
  • Experience in a small pharma company environment preferred. Must be comfortable with ambiguity in a small, fast-paced environment.

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