Associate Principal/Principal, Market Access Regulatory Strategy

Avalere Health • Washington, DC

16h • $150,000 - $200,000 • Hybrid

About The Position

Avalere Health is seeking an expert in 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 FDA 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 and draft scopes of work with quality solutions. A successful candidate will assist life science clients in navigating the evolving state and federal policy settings, as well as developing innovative solutions.

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.

Nice To Haves

• Preferred Regulatory Affairs Certification (RAC)

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.)

Benefits

• You will receive a 401K plan with an employer match contribution up to 4% (immediately vested), as well as life insurance, disability coverage, and medical, dental, and vision plans for peace of mind.
• Enjoy flexible working arrangements, including hybrid and remote work, along with the option to work from anywhere across the globe two weeks each year.
• We provide 20 vacation days plus one personal well-being day, recognise 9 public holidays, along with gifted end-of-year holidays and an early Summer Friday finish in June, July, and August.
• Access free counselling through our employee assistance program and personalized health support.
• Our enhanced maternity, paternity, family leave, and fertility policies provide support across every stage of your family-planning journey.
• You can also benefit from continuous opportunities to professionally develop with on-demand training, support, and global mobility opportunities across the business.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees