• 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.)

• Own the global regulatory roadmap supporting international expansion across key regions (e.g., EU, UK, Canada, China, Japan, Korea, ASEAN, LATAM, Middle East) • Assess regulatory feasibility for new markets, products, and formulations • Develop market entry strategies balancing speed-to-market with compliance and risk • Lead preparation, submission, and maintenance of product registrations, notifications, and approvals globally, with the assistance of consultants as necessary • Oversee technical dossiers, ingredient approvals, and formula assessments per jurisdiction • Manage post-approval lifecycle including renewals, variations, and amendments • Ensure compliance with country-specific import requirements including labeling, claims, customs documentation, tariffs, and certificates • Partner with Supply Chain and Logistics on cross-border compliance, HS codes, COO, COAs, and trade documentation • Support distributor and customs authority interactions where necessary • Monitor evolving global regulatory landscapes affecting dietary supplements, functional foods, nutraceuticals, cosmetics and devices. • Anticipate regulatory changes and proactively adjust strategy • Identify and mitigate regulatory, compliance, and product liability risks • Serve as a strategic advisor to Product Development on globally viable formulations and claims • Collaborate with Quality and Manufacturing on compliance with GMP, audits, required certifications and regulatory inspections • Train internal stakeholders on regulatory requirements and best practices • Act as primary Blueprint representative with global regulatory authorities and external consultants • Build relationships with international regulators, trade associations, and testing bodies • Manage third-party regulatory service providers efficiently and cost-effectively • Build and maintain regulatory SOPs, templates, and internal compliance systems • Ensure documentation supports audits, inspections, and due diligence (including support for M&A or investor reviews)

• Ensure adherence to federal, state, local, and payer regulations and contractual obligations in collaboration with Legal and Equip’s Privacy and Security Officers, staying current with evolving healthcare laws, including Medicaid requirements, and implement accreditation standards (e.g., The Joint Commission). • Develop, review, and update compliance policies, governance documents, and SOPs with clinical leaders, ensuring policies reflect current regulations. • Conduct internal compliance audits, focusing on high-risk workflows, and report material findings to relevant leaders across the organization. • Work cross-functionally to support external audits, monitor medical records as well as billing and coding for documentation and quality alignment. • Perform clinical risk assessments and track corrective actions for sustainable remediation. • Develop and deliver tailored compliance trainings, including regulatory updates, risk themes, onboarding integration, and annual targeted sessions based on audit insights. • Investigate compliance violations and incidents and manage compliance reporting systems, document incidents with root-cause analysis, and coordinate reporting with Legal and HR as required. • Identify and report any potential compliance risks within business workflows, cross-functional processes, and implement corrective actions and enforce Legal guidance on fraud, waste, and abuse. • Maintain all clinical compliance documentation, logs, registers, and evidence and create audit records and prepare leadership reports with actionable insights. • Liaise with payors and regulatory bodies, collaborate with internal and outside legal counsel on risk alignment, report systemic trends/mitigation progress to leadership, and support external audits (e.g. accreditation, payor, etc.). • Perform other duties as assigned.

• Create monthly reporting by analyzing and reporting on the effectiveness of IT security controls and risk exposure. • Assess and continuously monitor that all applicable regulatory requirements are met, and security controls are managed and maintained. • Perform information security risk evaluations on reported IT issues. • Advise and guide the business and IT partners on the appropriateness of security measures to mitigate risk and reduce risk exposure. • Educate the business and IT partners on alterative security measures where security requirements are unable to be met. • Track remediation plans through to successful implementation with the business and IT partners. • Participate in IT initiatives as necessary to ensure security control measures are addressed and imbedded in business-as-usual activities prior to project completion. • Develop information security processes and procedures and continuously improve security aspects of operating processes. • Serve as the primary point of contact for external auditors.