Senior Director – Regulatory Counsel

19 hours ago

Washington, Washington, D.C., United States PhRMA Full time
Job Title: Senior Director – Regulatory Counsel

The Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a highly skilled Senior Director to join our Law Department. As a key member of our team, you will serve as regulatory counsel and provide legal counsel and advocacy support on issues related to the regulation and approval of biopharmaceutical products.

Key Responsibilities:
  • Advise biopharmaceutical companies on FDA regulatory legal issues, including manufacturing, quality, and supply chain requirements.
  • Advocate on behalf of PhRMA and its members on legal and regulatory issues with the US Food and Drug Administration (FDA), Congress, the courts, and other law enforcement bodies and government agencies.
  • Provide primary legal support for PhRMA's advocacy on manufacturing and quality-related issues, including GMPs, inspection-related issues, and supply chain considerations.
  • Coordinate with external counsel and provide legal counsel to PhRMA's Scientific and Regulatory Advocacy Department.
  • Perform other duties as assigned.
Requirements:
  • JD and member of the DC Bar with at least 3+ years of experience in a law firm, as counsel in a biopharmaceutical company, or trade association.
  • Experience with FDA regulatory law and exceptional written and verbal communication skills.
  • Ability to manage multiple complex high-visibility priorities and communicate legal concepts and opinions to non-lawyers.
  • Strong negotiating skills and ability to facilitate meetings with, work with, and drive consensus among disparate stakeholders.
About PhRMA:

PhRMA represents the country's leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Our member companies have more than doubled their annual investment in the search for new treatments and cures, including nearly $101 billion in 2022 alone.

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