Description:

The individual in this position will provide solutions-oriented legal advice and support to a broad spectrum of internal clients from the following functions (e.g., Regulatory Strategy, Regulatory Policy, Safety, Quality, Clinical Development, Clinical Trial Transparency, and Publications). This position reports to the Director and Senior Counsel of Regulatory Legal.

Key Duties and Responsibilities:
  • Advise cross-functional project teams on regulatory law issues related to pipeline products (e.g., investigator meetings, GCP issues, IND safety reporting, IRB issues, development plans)
  • Provide solutions-oriented and strategic advice relating to the company's interactions with FDA, including crafting legal arguments for inclusion in regulatory submissions and helping teams prepare for formal meetings with FDA and advisory committee meetings
  • Advise on issues related to FDA's expedited programs for serious conditions, such as accelerated approval, fast track designation, breakthrough designation, priority review, as well as on exclusivity issues
  • Assist Quality organization in preparing for audits and inspections by regulatory authorities
  • Advise on legal questions relating to sunshine reporting and clinical trial transparency initiatives (e.g., ct.gov requirements, researcher requests for clinical trial data)
  • Participate in various other Legal & Compliance Department projects and initiatives

Applicable Knowledge and Skills:
  • Depth of knowledge of the laws, regulations and industry standards applicable to the area of responsibility
  • Significant understanding of business drivers
  • Strong analytical and complex problem-solving skills, sound judgment
  • Ability to constructively counsel and influence clients in making the right decisions, articulating legal concepts simply and clearly
  • Ability to work cross-functionally and independently
  • Capacity to simultaneously handle a variety of complex legal matters with minimal guidance
  • Ability to take ownership of issues
  • Ability to create buy-in and trust

Basic Requirements:
  • JD or LLM from an ABA accredited law school and member of a state bar
  • 6+ years' experience providing FDA regulatory advice to pharmaceutical, biotechnology, or medical device companies, whether in-house or in a law firm, or the equivalent combination of education and experience