Remote Associate Principal, FDA Regulatory Strategy & Policy

Summary

Join Avalere Health as an expert in legal and regulatory FDA strategy and policy to support the company's work in advisory services. The successful candidate will develop and drive the FDA regulatory strategy business through thought leadership and building client relationships.

Requirements

• 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
• 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

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 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

Benefits

• Generous company pension/retirement plan
• Private medical insurance
• Comprehensive employee wellbeing initiatives
• Compelling time-off policy