US Public Policy Lead – Pharma Implementation

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

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.