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Vice President, Regulatory Affairs, CNS Gene Therapy, SwanBio Therapeutics

Company: The Higgins Group
Location: Philadelphia
Posted on: September 17, 2020

Job Description:

The Company:SwanBio Therapeutics is a privately held gene therapy company that is headquartered outside of Philadelphia, PA and also has offices in Cambridge, MA. SwanBio is developing leading-edge medicines to deliver dramatic clinical efficacy for the treatment of neurological diseases. They are driven by an unrelenting passion to solve difficult challenges, and a belief that meaningful discovery is born of curiosity, collaboration, and compassion.The Position:Reporting to the CMO, the Vice President of Regulatory Affairs will be responsible for the global regulatory strategy and worldwide submissions for SwanBio development programs.--The incumbent will be responsible for planning and executing program applications, both in the US and ex-US, and will hold accountability for regulatory submissions, applicable communications, and compliance across the company's programs. S/he will focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment. Beyond that, the VP will assess the current infrastructure and plan to build the team out as business dictates.The ideal candidate will possess the following mix of personal and professional characteristics:Advanced degree in a scientific discipline (MS, PhD, PharmD) preferred, with at least 10 years of relevant regulatory experience.--Gene therapy experience is highly desirable and biologics experience is required.Experience working with Neurology and/or Rare/Orphan Disease groups at the FDA highly desirable.--Existing relationships with CBER is desired.Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration.--Both IND and BLA experience required.Ability to prepare, review, and submit high-quality documentation for INDs, CTAs, BLAs, and MAAS, and related filings to regulatory agencies within established timeframes. Responsibilities will include original applications and product maintenance, such as information amendments and annual reports.Ability to lead the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure regulatory requirements and strategy are understood by the project teams.Expertise in working with global regulatory authorities; specifically communicating and negotiating with FDA and other global regulatory agencies.Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval.A "hands-on", "roll-up-the-sleeves" when necessary leader that understands the need for involvement within a small company environment while recognizing when to delegate and seek results from the team.

Keywords: The Higgins Group, Philadelphia , Vice President, Regulatory Affairs, CNS Gene Therapy, SwanBio Therapeutics, Executive , Philadelphia, Pennsylvania

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