Avalere Health
Associate Principal, FDA Regulatory Strategy & Policy
Avalere Health, Washington, District of Columbia, us, 20022
About the Company
Avalere is a strategic advisory company whose core purpose is to create innovative solutions to complex healthcare problems. Based in Washington, DC, the firm delivers actionable insights, product solutions, and custom analytics for leaders in healthcare business and policy. Avalere's experts span 230 staff drawn from Fortune 500 healthcare companies, the federal government (e.g., CMS, OMB, CBO and the Congress), top consultancies and nonprofits. The firm offers deep substance on the full range of healthcare business issues affecting the Fortune 500 healthcare companies. Avalere’s focus on strategy is supported by a rigorous, in-house analytic research group that uses public and private data to generate quantitative insight. Through events, publications and interactive programs, Avalere insights are accessible to a broad range of customers.
Avalere is part of a parent company Avalere Health, a purposefully built commercialization partner for the biopharmaceutical, medical technology, and wellness industries. Its 1,500+ experts combine their knowledge and expertise across our core disciplines—Consulting; Medical; Policy, Access, Value, and Evidence; Marketing; and Digital Experience and Technology—to create the connections that make better health happen.
About the role Avalere Health is seeking an expert in legal and 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 Agency 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 to deliver on scopes of work with quality solutions. A successful candidate will assist life science clients in navigating these evolutions in the state and federal settings, as well as develop innovative solutions.
What you’ll do
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
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
Possess critical thinking, curiosity and an eagerness to connect the dots from historic precedents to upcoming business implications
About You
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, with 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.
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 prior regulatory affairs life science industry and/or FDA experience.
Preferred Regulatory Affairs Certification (RAC).
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Avalere is part of a parent company Avalere Health, a purposefully built commercialization partner for the biopharmaceutical, medical technology, and wellness industries. Its 1,500+ experts combine their knowledge and expertise across our core disciplines—Consulting; Medical; Policy, Access, Value, and Evidence; Marketing; and Digital Experience and Technology—to create the connections that make better health happen.
About the role Avalere Health is seeking an expert in legal and 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 Agency 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 to deliver on scopes of work with quality solutions. A successful candidate will assist life science clients in navigating these evolutions in the state and federal settings, as well as develop innovative solutions.
What you’ll do
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
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
Possess critical thinking, curiosity and an eagerness to connect the dots from historic precedents to upcoming business implications
About You
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, with 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.
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 prior regulatory affairs life science industry and/or FDA experience.
Preferred Regulatory Affairs Certification (RAC).
#J-18808-Ljbffr