Azurity Pharmaceuticals
VP, General Counsel, Government Affairs
Azurity Pharmaceuticals, Raleigh, North Carolina, United States, 27601
Overview
VP, Government Affairs at Azurity Pharmaceuticals. Reporting to Chief Legal & Compliance Officer, the Vice President of Government Affairs will lead the company’s global engagement with government entities, advocacy organizations, and market access stakeholders, shaping public policy and regulatory environments to support business objectives across key and emerging markets. This executive will serve as the primary liaison with policymakers, trade associations, and advocacy groups, ensuring the company’s voice is heard on legislative, regulatory, and access-related issues affecting the pharmaceutical industry worldwide. This executive will also serve as a strategic advisor to the executive leadership team, Board of Directors, and investors on policy trends, risks, and opportunities. The role includes oversight of public affairs and supporting the Communications team on external communications related to policy, reputation, and corporate positioning. The position will be the first dedicated government affairs role at the company and will be responsible for setting up Azurity’s government affairs strategy and program. Initially, the role will be that of an individual contributor but plans to expand the team may be considered based on strategy proposals from this role.
Key Responsibilities
Develop and execute a comprehensive global government affairs and market access strategy aligned with the company’s commercial, compliance, and public health goals.
Monitor, analyze, and respond to legislative, regulatory, and reimbursement developments in the U.S., international markets, and emerging economies, including agencies such as FDA, CMS, HHS, EMA, PMDA, ANVISA, and WHO.
Strategically advise the executive leadership team, the Board of Directors, and investors, providing briefings and insights on policy developments, regulatory risks, and government affairs initiatives.
Build and maintain strong relationships with elected officials, regulatory bodies, industry associations, advocacy groups, and health technology assessment (HTA) agencies.
Represent the company in industry forums, global industry coalitions, policy roundtables, and strategic partnerships with global pharmaceutical associations and public health organizations.
Commercial and Market Access Partnership & Advocacy
Partner with Market Access and Commercial teams to align policy and pricing strategies that support product launches and lifecycle management across US and global markets.
Lead advocacy efforts on issues such as drug pricing, reimbursement, market access, intellectual property, and healthcare reform globally, focusing on navigating complex regulatory and access landscapes.
Support modeling, execution, and ongoing evaluation of commercial strategies in alignment with company objectives and government regulations.
Contribute to the development of government price submissions, certifications, and overall GTN forecasting, ensuring alignment with market access expectations.
Oversight of External Partners
Oversee external consultants, lobbyists, and government relations vendors in multiple regions.
Compliance
Ensure compliance with pricing policies and regulations such as FSS, AMP, and price transparency. Support business teams responsible for these activities.
Ensure compliance with all lobbying disclosure, transparency, and ethics regulations in each operating country.
Qualifications
15+ years of experience in government affairs, public policy, or regulatory strategy, with at least 5 years in a global or international role within the pharmaceutical or healthcare sector.
Minimum 5+ years of proven success in supporting government pricing strategies and compliance.
Proven ability to build and sustain partnerships with advocacy organizations, patient groups, and public health coalitions.
Deep knowledge of U.S. and international healthcare policy, drug development and approval processes, and reimbursement systems (e.g., Medicare, Medicaid, EMA, NICE, HTA bodies).
S. Payer System Knowledge: expertise in Medicare, Medicaid, and the U.S. healthcare system.
Strong understanding of global market access dynamics, including payer engagement, HTA processes, and pricing and reimbursement frameworks.
Experience working with government and regulatory bodies in emerging markets (e.g., Latin America, Southeast Asia, Africa) is a plus.
Strong leadership, communication, and strategic thinking skills.
JD, MPH, MBA, or advanced degree in public policy, law, or related field preferred.
Multilingual capabilities and international work experience are strong assets.
Physical & Mental Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to sit for long periods of time
Frequently required to stand; walk; sit; talk and/or hear
May occasionally climb stairs and/or ride elevators
Occasionally lift and/or move up to 25 pounds
Must be able to manipulate keyboard, operate a telephone and hand-held devices
Other miscellaneous job duties as required
Benefits We Offer
Competitive compensation package, including an annual bonus based on company performance.
Sales - Incentive compensation program in lieu of annual bonuses to potentially exceed plan.
Car reimbursement program and gas card for business and personal use (Sales role).
Comprehensive health coverage for medical, dental, vision, and prescription drugs.
Hybrid work model: two days from home, three days in the office (excludes Sales, Manufacturing, and some Operations roles).
Retirement Savings Plan (401K) with employer matching up to 5%.
Generous vacation (up to 15 days annually, plus rollover up to 40 hours) and five sick/wellness days; vacation accrual prorated for new hires.
Extended time off between Christmas and New Year’s; 13 holidays per year.
Tuition reimbursement for undergraduate and graduate-level courses or certifications.
Recognition through the Azurity High Five program.
Note: This refined job description is intended to convey information essential to understanding the scope of the role and the requirements for the VP, Government Affairs position. The content reflects the original information with formatting improvements and removal of non-essential boilerplate.
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Key Responsibilities
Develop and execute a comprehensive global government affairs and market access strategy aligned with the company’s commercial, compliance, and public health goals.
Monitor, analyze, and respond to legislative, regulatory, and reimbursement developments in the U.S., international markets, and emerging economies, including agencies such as FDA, CMS, HHS, EMA, PMDA, ANVISA, and WHO.
Strategically advise the executive leadership team, the Board of Directors, and investors, providing briefings and insights on policy developments, regulatory risks, and government affairs initiatives.
Build and maintain strong relationships with elected officials, regulatory bodies, industry associations, advocacy groups, and health technology assessment (HTA) agencies.
Represent the company in industry forums, global industry coalitions, policy roundtables, and strategic partnerships with global pharmaceutical associations and public health organizations.
Commercial and Market Access Partnership & Advocacy
Partner with Market Access and Commercial teams to align policy and pricing strategies that support product launches and lifecycle management across US and global markets.
Lead advocacy efforts on issues such as drug pricing, reimbursement, market access, intellectual property, and healthcare reform globally, focusing on navigating complex regulatory and access landscapes.
Support modeling, execution, and ongoing evaluation of commercial strategies in alignment with company objectives and government regulations.
Contribute to the development of government price submissions, certifications, and overall GTN forecasting, ensuring alignment with market access expectations.
Oversight of External Partners
Oversee external consultants, lobbyists, and government relations vendors in multiple regions.
Compliance
Ensure compliance with pricing policies and regulations such as FSS, AMP, and price transparency. Support business teams responsible for these activities.
Ensure compliance with all lobbying disclosure, transparency, and ethics regulations in each operating country.
Qualifications
15+ years of experience in government affairs, public policy, or regulatory strategy, with at least 5 years in a global or international role within the pharmaceutical or healthcare sector.
Minimum 5+ years of proven success in supporting government pricing strategies and compliance.
Proven ability to build and sustain partnerships with advocacy organizations, patient groups, and public health coalitions.
Deep knowledge of U.S. and international healthcare policy, drug development and approval processes, and reimbursement systems (e.g., Medicare, Medicaid, EMA, NICE, HTA bodies).
S. Payer System Knowledge: expertise in Medicare, Medicaid, and the U.S. healthcare system.
Strong understanding of global market access dynamics, including payer engagement, HTA processes, and pricing and reimbursement frameworks.
Experience working with government and regulatory bodies in emerging markets (e.g., Latin America, Southeast Asia, Africa) is a plus.
Strong leadership, communication, and strategic thinking skills.
JD, MPH, MBA, or advanced degree in public policy, law, or related field preferred.
Multilingual capabilities and international work experience are strong assets.
Physical & Mental Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must be able to sit for long periods of time
Frequently required to stand; walk; sit; talk and/or hear
May occasionally climb stairs and/or ride elevators
Occasionally lift and/or move up to 25 pounds
Must be able to manipulate keyboard, operate a telephone and hand-held devices
Other miscellaneous job duties as required
Benefits We Offer
Competitive compensation package, including an annual bonus based on company performance.
Sales - Incentive compensation program in lieu of annual bonuses to potentially exceed plan.
Car reimbursement program and gas card for business and personal use (Sales role).
Comprehensive health coverage for medical, dental, vision, and prescription drugs.
Hybrid work model: two days from home, three days in the office (excludes Sales, Manufacturing, and some Operations roles).
Retirement Savings Plan (401K) with employer matching up to 5%.
Generous vacation (up to 15 days annually, plus rollover up to 40 hours) and five sick/wellness days; vacation accrual prorated for new hires.
Extended time off between Christmas and New Year’s; 13 holidays per year.
Tuition reimbursement for undergraduate and graduate-level courses or certifications.
Recognition through the Azurity High Five program.
Note: This refined job description is intended to convey information essential to understanding the scope of the role and the requirements for the VP, Government Affairs position. The content reflects the original information with formatting improvements and removal of non-essential boilerplate.
#J-18808-Ljbffr