Description:
Overview:The A Trade Group Representing Companies in The Pharmaceutical Industry is seeking a Senior Director in the Law Department. The Senior Director will serve as regulatory counsel and provide both legal counsel and advocacy support along with other members of the Law team on issues relating to the regulation and approval of biopharmaceutical products (e.g., issues relating to reauthorization and implementation of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), new drug approval, clinical trials, manufacturer communication, post market safety, and manufacturing). Specific experience advising biopharmaceutical companies on FDA regulatory legal issues including manufacturing, quality, and supply chain requirements (e.g., GMPs, DSCSA, inspection-related issues), FDA's regulation of digital health products and artificial intelligence and/or Hatch-Waxman and BPCIA is preferred.
The Senior Director will report to the Vice President, Law/Senior Counsel for Biopharmaceutical Regulation, and will work with other PhRMA lawyers and regulatory professionals working in the relevant subject matter areas.
The Senior Director will:
- Serve as legal counsel for issues related to the above and assure appropriate collaboration among staff;
- 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;
- Serve as legal staff lead on PhRMA's engagement on FDA digital health and artificial intelligence policies;
- Coordinate with external counsel;
- Provide legal counsel to PhRMA's Scientific and Regulatory Advocacy Department;
- Provide and coordinate support to federal and state advocacy teams on issues relating to FDA regulatory issues;
- Coordinate legal issue alignment with member company in-house counsel;
- Provide general legal back-up for PhRMA activity in other substantive areas;and
- Perform other duties as assigned.
Key Success Factors:
PhRMA seeks a collaborative, proactive, self-starter who is passionate about FDA regulatory law and addressing the healthcare challenges we face today. The ideal candidate for this role will be a relationship builder, problem solver and analytical thinker. The individual should have a high level of emotional intelligence, professional presence and the ability to engage others and inspire confidence. Key success factors for this role include intellectual curiosity, strong interpersonal and communication skills, acute political sensitivity and diplomacy and a team focus paired with the ability to work independently. The successful candidate should be adaptable, be able to reprioritize/shift gears quickly and be comfortable in a high-pressure environment.
Professional Experience / Requirements:
- JD and member of the DC Bar with at a minimum of 3+ years of experience in a law firm, as counsel in a biopharmaceutical company or trade association or other non-profit or as a public servant in a relevant government department, agency or Congress;
- Experience with FDA regulatory law;
- Exceptional written and verbal communication skills;
- Ability to manage multiple complex high-visibility priorities;
- Ability to communicate legal concepts and opinions to non-lawyers both verbally and in writing;
- Ability to facilitate meetings with, work with and drive consensus among disparate stakeholders; and
- Strong negotiating skills.
