Associate Principal/Principal, Market Access Regulatory Strategy
Posted 2026-05-06
Remote, USA
Full-time
Immediate Start
- Job Description:
- 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 Health clients, managing and anticipating specific client needs
- Lead and contribute to broader projects (e.g., policy, market access, evidence, global) 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
- Represent Avalere Health in public forums (e.g., webinars, conference panels, etc.)
- Requirements:
- Qualified candidates should possess an advanced degree in law, public health administration, or advanced degree (PhD, PharmD, MD, DrPH, JD), or have relevant work experience.
- A minimum of 8+ years of experience in healthcare is required, with prior experience working in the FDA and/or pharmaceutical or biotech manufacturers preferred in a regulatory affairs 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 Regulatory Affairs Certification (RAC)
- Benefits:
- You will receive a 401K plan with an employer match contribution up to 4% (immediately vested)
- Life insurance
- Disability coverage
- Medical, dental, and vision plans
- Flexible working arrangements, including hybrid and remote work
- Option to work from anywhere across the globe two weeks each year
- 20 vacation days plus one personal well-being day
- Recognise 9 public holidays
- Gifted end-of-year holidays
- Early Summer Friday finish in June, July, and August
- Access free counselling through our employee assistance program
- Personalized health support
- Enhanced maternity, paternity, family leave, and fertility policies with support across every stage of your family-planning journey
- Opportunities to professionally develop with on-demand training, support, and global mobility opportunities