Avalere Health · 5 hours ago
Associate Principal/Principal, Market Access Regulatory Strategy
United States
Full-time
Hybrid
Senior Level, Lead/Staff
$150K/yr - $200K/yr
8+ years expAvalere Health is dedicated to ensuring every patient is identified, treated, supported, and cared for. The role involves developing and driving FDA regulatory strategy business, providing thought leadership, and managing client relationships in the healthcare sector.
Brand MarketingConsultingMedical
Responsibilities
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.)
Qualification
Required
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
Ability to speak and write thoughtfully on such matters to a variety of audiences, internally and externally
Possess critical thinking, curiosity and an eagerness to connect the dots from historic precedents to upcoming business implications
Preferred
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
401K plan with an employer match contribution up to 4% (immediately vested)
Life insurance
Disability coverage
Medical, dental, and vision plans
20 vacation days plus one personal well-being day
9 public holidays
Gifted end-of-year holidays
Early Summer Friday finish in June, July, and August
Free counselling through our employee assistance program
Personalized health support
Enhanced maternity, paternity, family leave, and fertility policies
Continuous opportunities to professionally develop with on-demand training, support, and global mobility opportunities across the business
Company
Avalere Health
Avalere Health offers business consulting, medical engagement and communications services.
1001-5000 employees
H1B Sponsorship
Avalere Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2022 (6)
2021 (3)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Amar Urhekar
Chief Executive Officer
Corrina Safeio
President Global Marketing, EVP Corporate Marketing
Recent News
2025-12-04
Company data provided by crunchbase