Senior Director, Law (FDA Regulatory)
PHRMA
Summary
PhRMA is seeking a Senior Director in the Law Department to serve as FDA regulatory counsel and provide legal counsel and advocacy support on issues relating to the FDA regulation and approval of biopharmaceutical products.
Job description
Responsibilities
- Serve as legal counsel for issues related to FDA regulation and approval of biopharmaceutical products and ensure appropriate collaboration among staff
- Advocate on behalf of PhRMA and its members on legal and regulatory issues with the FDA, Congress, the courts and other government agencies
- Coordinate with external counsel
- Provide legal counsel to PhRMA's Scientific and Regulatory Advocacy Department, including support of comment development on scientific and technical issues
- Provide and coordinate support to federal and state advocacy teams on FDA regulatory issues
- Track open FDA related legislation, FDA dockets, and commenting opportunities
- Coordinate legal issue alignment with member company in-house counsel
- Provide general legal back-up for PhRMA activity in other substantive areas
- Perform other duties as assigned
Key Success Factors
PhRMA seeks a collaborative, proactive, self-starter who is passionate about FDA regulatory law. The ideal candidate will be a relationship builder, problem solver and analytical thinker who can translate complex legal issues into clear, actionable advice and messaging. The individual should have high emotional intelligence, professional presence, strong interpersonal and communication skills, political sensitivity and diplomacy, and the ability to work independently in a high-pressure environment.
Requirements
- JD degree
- Member of the DC Bar
- 3 to 7 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
- Strong negotiating skills
Benefits
- Medical, Dental & Vision
- Flexible Spending Account
- Life & AD&D Insurance
- LTD & STD
- Parental Leave
- Well-being Program
- On-site Fitness Facility
- Back-up Care
- Health Advocate Service
- Employee Assistance Program
- Commuting Benefits
- 401(k) Matching
- Paid Time Off
- Paid Holidays
- Winter Break
- Tuition Reimbursement
- Leadership Development
Company overview
The Pharmaceutical Research and Manufacturers of America (PhRMA) is the leading trade association representing America's innovative biopharmaceutical research companies. Founded in 1958 and headquartered in Washington, D.C., PhRMA advocates for public policies that encourage the discovery and development of new medicines while ensuring patient access to safe, effective treatments. The organization represents more than 30 of the world's leading research-intensive pharmaceutical companies, including Pfizer, Merck, Johnson & Johnson, and AstraZeneca. PhRMA's mission focuses on advancing innovation, making medicines more affordable, and creating a more equitable healthcare system. The association works at federal and state levels to protect intellectual property rights, promote transparent regulation, and advocate against government price controls that could hinder future medical innovation. Through initiatives like the Partnership for Prescription Assistance and SMARxT Disposal program, PhRMA demonstrates its commitment to patient welfare and environmental responsibility. With approximately 200-500 employees, the organization serves as a critical voice in shaping healthcare policy and maintaining America's leadership in biopharmaceutical innovation.