Senior Director, Law (FDA Regulatory)
- Salary
- $195.8K–$273.8K
- Hiring from
- United States
- Work type
- Hybrid
- Posted
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Overview
The Pharmaceutical Research and Manufacturers of America (PhRMA) is seeking a Senior Director in the Law Department. The Senior Director will serve as FDA regulatory counsel and provide both legal counsel and advocacy support, along with other members of the Law team on issues relating to the FDA 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 communications, post market safety, and manufacturing). Specific experience advising biopharmaceutical companies on FDA regulatory and legal issues, including clinical trials and clinical development, orphan drugs, vaccines, new approach methodologies and the regulation of digital health products and artificial intelligence, is preferred. Familiarity with vaccine issues outside of the FDA space, including ACIP, VICP, and CDC, as well as the FDA-related issues in the Inflation Reduction Act, is a plus.
The Senior Director will report to the Vice President, Law/Senior Counsel for Biopharmaceutical Regulation and be part of the Regulatory Law team 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 ensure 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;
- Coordinate with external counsel;
- Provide legal counsel to PhRMA’s Scientific and Regulatory Advocacy Department, including through the 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; and
- 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 and addressing the healthcare challenges we face today. The ideal candidate for this role will be a relationship builder, problem solver and analytical thinker who can translate complex legal issues into clear, actionable advice and messaging for internal clients. The individual should be able to craft audience-appropriate communications for a wide range of stakeholders, including technical subject matter experts, lay audiences, and internal and member company lobbyists. 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, be able to advocate on behalf of PhRMA, and be comfortable in a high-pressure environment.
Professional Experience / Requirements
- JD and member of the DC Bar with 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; and
- Strong negotiating skills.
Potential Salary
$195,800-273,800 per annum. Salary is commensurate with experience and other compensable factors.
Who we are
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research companies, which are laser focused on developing innovative medicines that transform lives and create a healthier world. Together, we are fighting for solutions to ensure patients can access and afford medicines that prevent, treat and cure disease. PhRMA member companies have invested more than $900 billion in the search for new treatments and cures over the last decade, supporting nearly five million jobs in the United States.
Connect with PhRMA
For information on how innovative medicines save lives, please visit:
www.PhRMA.org
What we offer
In addition to a highly competitive salary and bonus program, various opportunities for reward and recognition and a platform of extensive benefits, PhRMA is committed to the development and overall wellbeing of our team members. We offer traditional (medical, dental, vision, flexible spending, life, AD&D, LTD, STD) and enhanced benefits such as parental leave, a well-being program, an on-site fitness facility, back-up care, health advocate service, an employee assistance program, and commuting benefits. We also offer a robust 401k plan with employer contributions upon the first day of hire and immediate vesting, a generous paid time off plan, ten paid holidays (plus inauguration day), half day Fridays preceding holidays, half day Fridays in the summer months, and a paid winter break. As an organization, we work together in the office on Mondays through Thursdays and remotely on Fridays. We also all work remotely in August.
We are committed to the growth and development of our team members and offer many learning opportunities including an integrated onboarding program, best-in-class leadership programming, tuition reimbursement, industry on-site and off-site training, and other management/professional development programs. Corporate social responsibility is also important to us at PhRMA. Our team members participate in community service activities, fundraising drives and charitable athletic events.
We are committed to supporting our family of professionals at PhRMA and strive to create programs that help our team members manage the challenges of balancing a fast-paced career with their personal goals.
Equal Opportunity Employer
PhRMA provides equal employment opportunities to all applicants without regard to race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, gender identity or expression, family responsibilities, genetic information, disability, matriculation, political affiliation or veteran status in accordance with applicable federal, state and local laws governing nondiscrimination in employment.
The job description contains an overview of the activities and duties for this role. Responsibilities may change and new ones may be assigned at any time.
