Senior Director – Law (Regulatory)

Overview

The Pharmaceutical Research and Manufacturers of America (PhRMA) 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.

TheSenior Directorwill

• 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.
  
  

Potential Salary

$141,100-197,500 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 devoted to discovering and developing medicines that enable patients to live longer, healthier and more productive lives. Over the last decade, PhRMA member companies have more than doubled their annual investment in the search for new treatments and cures, including nearly $101 billion in 2022 alone.

Connect with PhRMA

For information on how innovative medicines save lives, please visit:

www.PhRMA.org

www.Innovation.org

www.MAT.org

www.Facebook.com/PhRMA

www.Twitter.com/PhRMA

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, LTC) and enhanced benefits such as parental leave, a well-being program, back-up care, health advocate service, 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, seven 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 remotely on Mondays and Fridays and together in the office on Tuesdays through Thursdays. 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 at both the undergraduate and graduate levels, industry on-site and off-site training, and other management/professional development programs. Corporate social responsibility is also important to us at PhRMA.

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 own 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.