Associate Principal/Principal, Market Access Regulatory Strategy

About This Role

Lead and drive the FDA regulatory strategy business within Advisory Services by providing thought leadership, building client relationships, and managing complex regulatory projects for life science clients. This role focuses on adapting to evolving FDA dynamics and informing business development strategies.

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
• 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
• Represent Avalere Health in public forums (e.g., webinars, conference panels, etc.)

Requirements

• Advanced degree (PhD, PharmD, MD, DrPH, JD) or relevant work experience
• 8+ years of experience in healthcare
• 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

Qualifications

• Advanced degree in law, public health administration, or advanced degree (PhD, PharmD, MD, DrPH, JD), or relevant work experience
• 8+ years of experience in healthcare, with prior experience working in the FDA and/or pharmaceutical or biotech manufacturers preferred in a regulatory affairs capacity

Nice to Have

• Prior experience working in the FDA
• Experience in pharmaceutical or biotech manufacturers in a regulatory affairs capacity
• Previous consulting experience
• Previous management and supervisory experience

Skills

* Required skills

Benefits

Certifications