Associate Principal/Principal, Market Access Regulatory Strategy
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
Apply Now
Apply Now
• 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
Apply Now
Apply Now