NEW: US Public Policy Lead - Pharmaceuticals

G&L Scientific; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

G&L Scientific is seeking a US Public Policy Lead to interpret emerging FDA guidance and healthcare policy, assess implications for pharmaceutical development, and translate policy changes into implementable plans and pilot programmes.

You will collaborate across Regulatory Affairs, Legal, Quality and Clinical Development to drive policy-driven initiatives, monitor pricing and access developments, and brief senior leadership on strategic impact.

Qualifications

• Significant experience in US pharmaceutical policy, regulatory policy, government affairs or a closely related discipline.
• Experience within a pharmaceutical or biotechnology organisation.
• Strong understanding of the US FDA regulatory environment and the ability to interpret new policies and guidance.
• Demonstrated ability to translate policy or regulatory changes into practical implementation plans.
• Experience coordinating cross-functional initiatives, pilots or process changes.
• Strong stakeholder-management, analytical and communication skills.
• Ability to advise senior stakeholders and operate effectively in a complex, regulated environment.
• Experience supporting the implementation or piloting of new FDA guidance, regulatory initiatives or policy changes.
• Experience working across Regulatory Affairs, Public Policy, Legal, Quality and other pharmaceutical functions.
• Knowledge of US healthcare legislation, pharmaceutical pricing reform, Medicare, Medicaid and market access.
• Experience evaluating pilot outcomes and developing recommendations for broader implementation.

Responsibilities

• Monitor and interpret new FDA policies, regulatory guidance and relevant US healthcare legislation.
• Assess the operational and strategic implications of policy changes for pharmaceutical development and business processes.
• Translate new guidance into practical recommendations, implementation plans and pilot initiatives.
• Facilitate cross-functional pilot programmes, coordinating stakeholders, defining objectives and supporting delivery.
• Work with Regulatory Affairs, Legal, Government Affairs, Quality, Clinical Development and other relevant teams to assess requirements and implementation considerations.
• Monitor federal healthcare policy, pharmaceutical pricing reform, Medicare, Medicaid and patient access developments.
• Prepare policy assessments, impact analyses, briefing materials and recommendations for senior leadership.
• Track pilot progress, capture learnings and support recommendations for wider implementation where appropriate.

Job description

NEW: US Public Policy Lead - Pharmaceuticals

We are seeking an experienced US Public Policy professional to support the interpretation and implementation of emerging healthcare policy and regulatory guidance within a global pharmaceutical organization.

The role will focus on assessing new FDA policies and guidance, understanding their implications for the business, and working cross-functionally to translate policy changes into practical implementation plans and pilot programmes.

The successful candidate will also support broader US healthcare policy priorities, including pharmaceutical pricing, market access and patient affordability, advising stakeholders on emerging developments and their potential impact on business operations and strategy.

The Role

• Monitor and interpret new FDA policies, regulatory guidance and relevant US healthcare legislation.
• Assess the operational and strategic implications of policy changes for pharmaceutical development and business processes.
• Translate new guidance into practical recommendations, implementation plans and pilot initiatives.
• Facilitate cross-functional pilot programmes, coordinating stakeholders, defining objectives and supporting delivery.
• Work with Regulatory Affairs, Legal, Government Affairs, Quality, Clinical Development and other relevant teams to assess requirements and implementation considerations.
• Monitor federal healthcare policy, pharmaceutical pricing reform, Medicare, Medicaid and patient access developments.
• Prepare policy assessments, impact analyses, briefing materials and recommendations for senior leadership.
• Track pilot progress, capture learnings and support recommendations for wider implementation where appropriate.

Requirements

• Significant experience in US pharmaceutical policy, regulatory policy, government affairs or a closely related discipline.
• Experience within a pharmaceutical or biotechnology organisation.
• Strong understanding of the US FDA regulatory environment and the ability to interpret new policies and guidance.
• Demonstrated ability to translate policy or regulatory changes into practical implementation plans.
• Experience coordinating cross-functional initiatives, pilots or process changes.
• Strong stakeholder-management, analytical and communication skills.
• Ability to advise senior stakeholders and operate effectively in a complex, regulated environment.
• Experience supporting the implementation or piloting of new FDA guidance, regulatory initiatives or policy changes.
• Experience working across Regulatory Affairs, Public Policy, Legal, Quality and other pharmaceutical functions.
• Knowledge of US healthcare legislation, pharmaceutical pricing reform, Medicare, Medicaid and market access.
• Experience evaluating pilot outcomes and developing recommendations for broader implementation.

Ideal Candidate:

The ideal candidate will combine strong US policy and regulatory knowledge with practical implementation experience.

They will be able to interpret emerging FDA guidance, assess its implications, bring the right stakeholders together and facilitate pilot programmes that translate new requirements or opportunities into workable business processes.

They will be confident operating across policy, regulatory and operational teams, with the ability to turn complex guidance into clear, actionable recommendations.

If you have experience interpreting US FDA policy and facilitating the implementation of new initiatives within the pharmaceutical industry, we welcome a confidential conversation.