Associate Principal, FDA Regulatory Strategy & Policy

Avalere is a strategic advisory company whose core purpose is to create innovative solutions to complex healthcare problems. Based in Washington, DC, the firm delivers actionable insights, product solutions, and custom analytics for leaders in healthcare business and policy. Avalere's experts span 230 staff drawn from Fortune 500 healthcare companies, the federal government (e.g., CMS, OMB, CBO and the Congress), top consultancies and nonprofits. The firm offers deep substance on the full range of healthcare business issues affecting the Fortune 500 healthcare companies. Avalere’s focus on strategy is supported by a rigorous, in-house analytic research group that uses public and private data to generate quantitative insight. Through events, publications and interactive programs, Avalere insights are accessible to a broad range of customers.

Avalere is part of a parent company Avalere Health, a purposefully built commercialization partner for the biopharmaceutical, medical technology, and wellness industries. Its 1,500+ experts combine their knowledge and expertise across our core disciplines—Consulting; Medical; Policy, Access, Value, and Evidence; Marketing; and Digital Experience and Technology—to create the connections that make better health happen. Visit www.avalere.com and follow Avalere Health on LinkedIn and Instagram.

Avalere Health is seeking an expert in legal and regulatory FDA strategy and policy to support Avalere’s work in advisory services. The successful candidate will be responsible for developing and driving the FDA regulatory strategy business through thought leadership and building client relationships. The candidate should possess a forward-looking ability to readily adapt to evolving legislative and Agency dynamics, particularly in light of FDA’s evolving role in health policy beyond traditional regulatory matters, to inform business development strategies. Additionally, the candidate should be prepared to lead FDA-regulatory strategy projects to deliver on scopes of work with quality solutions. A successful candidate will assist life science clients in navigating these evolutions in the state and federal settings, as well as develop innovative solutions.

·       Provide thought leadership expertise via analyses and external dissemination of key regulatory insights and implications on commercialization strategies

·       Understand intersection of regulatory strategy with commercial and market access stakeholders

·       Drive business development with key regulatory affairs and intelligence professionals within the biopharmaceutical and biotech industry 

·       Ability to speak and write thoughtfully on such matters to a variety of audiences, internally and externally

·       Interface with a portfolio of Avalere clients, managing and anticipating specific client needs

·       Lead and contribute to projects as a regulatory subject matter expert

·       Solve complex client queries related to governing statute, applicable regulations and technical guidance on drug development and FDA oversight with rigor and agility

·       Build industry partnerships and connections to deepen Avalere’s strategic visibility in regulatory strategy and FDA policy

·       Lead, manage, supervise, train and mentor junior and mid-level staff members across the firm

·       Possess critical thinking, curiosity and an eagerness to connect the dots from historic precedents to upcoming business implications

 

·       Qualified candidates should possess an advanced degree in law or public health administration, or have relevant work experience.

·       A minimum of 8+ years of experience in the healthcare is required, with prior experience working in the FDA and/or pharmaceutical or biotech manufacturers preferred in a regulatory capacity.

·       Candidates must demonstrate significant experience in navigating new developments in the regulation of drugs, biologics, and devices by the FDA and/or the related scientific and policy issues.

·       Previous consulting experience is preferred but not essential, provided that the candidate is an outstanding communicator and enjoys working with clients. 

·       Previous management and supervisory experience preferred.

·       Preferred prior regulatory affairs life science industry and/or FDA experience

·       Preferred Regulatory Affairs Certification (RAC) 

Established in 2001, Avalere Health is a purposefully built commercialization partner for the biopharmaceutical, medical technology, and wellness industries.

Our 1,500+ experts combine their knowledge and expertise across our core disciplines — Consulting; Medical; Policy; Value, Evidence, and Access; Marketing; and Digital Experience Technology — to create the connections that make better health happen.

Avalere Health partners with its clients to navigate the complex and rapidly changing healthcare ecosystem. Together, our experts help clients connect patients with life-changing therapies, realizing the potential of strategies and solutions to accelerate innovation that improves lives.

We live and breathe our five values in everything we do: We are authentic. We act with integrity. We value difference. We play for the team. We enjoy the journey. At Avalere Health, we imagine a healthier world and create the connections to make it happen. 

We take pride in being part of the Disability Confident Scheme. This helps make sure you can be interviewed fairly if you have a disability, long term health condition, or are neurodiverse. If you'd like to apply and need adjustments made, you can let us know in your application.

Avalere Health aims to empower every employee to develop and thrive. We empower our team with the tools, skills, and support needed to think differently and to solve healthcare’s most complex challenges.

At the center of our people-led culture is our Career Experience team, whose mission is to provide every employee with a purpose-driven career. We also pride ourselves on our personalized learning approach to ensure you receive the training you need to help you grow within the company and take advantage of our global scale and scope.

We are committed to embedding diversity and inclusion in every aspect of our organization. We encourage diversity of thought, inclusive behavior, and break down barriers to ensure every individual feels valued and encouraged to contribute their unique abilities and potential. As part of our commitment to building a healthier world, every employee is also encouraged to participate in our community engagement efforts, which support a wide range of healthcare programs and wellbeing causes worldwide.

We have city hubs across North America, Europe, and Asia, geared toward collaborating, training, socializing, and coming together as a global organization while maintaining and fully supporting flexible working practices. Our compensation and benefits package is benchmarked across the industry. We offer a generous company pension/retirement plan, private medical insurance, comprehensive employee wellbeing initiatives, compelling time-off policy, plus many other excellent employee benefits. 

We encourage all applicants to read our candidate privacy notice before applying to Avalere Health.