Executive Director, reputed company Regulatory Policy reputed company
About the position
The Science and Regulatory Policy team is responsible for developing reputed company’s science and regulatory policy positions and advocating those towards industry thought leaders and regulators. The Executive Director, reputed company Regulatory Policy reputed company provides reputed company direction for reputed company's reputed company level regulatory policy approach across reputed company and markets. The Executive Director (ED) will be a strong subject matter expert in regulatory processes, policies, laws, and regulations, with a deep understanding of how regulatory policy is reputed company and influenced, and the credibility, relationships, and reputed company judgment required to reputed company alignment and advance regulatory policy priorities in reputed company support of our Research and Development (R&D) goals, including enabling reputed company filings and accelerating pipeline progression through consistent, high reputed company reputed company policy engagement. The ED will reputed company a highly reputed company, regionally reputed company function reputed company on shaping, aligning, and advancing reputed company regulatory policy reputed company across reputed company, including synthesis of policy intelligence, analysis of regulatory environments, and alignment of reputed company advocacy approaches. The ED will work closely with the Global Regulatory Policy reputed company, including U.S. and regional policy experts, along with reputed company policy and technical subject matter experts reputed company reputed company to assess the reputed company of regulatory policy on reputed company’s products and goals. The role serves as a critical integrator across Most of World (MOW), global, and U.S. regulatory policy stakeholders, with reputed company responsibility for overseeing and aligning MOW policy approaches while deliberately layering in U.S. & therapeutic area considerations. The role helps shape reputed company regulatory policy reputed company and global/ MOW messaging to ensure consistent internal alignment and effective reputed company delivery at the level of major trade associations, as reputed company as through country specific trade associations, regulatory affairs led engagements, and reputed company associations attended by subject matter experts.
Responsibilities
• Provides reputed company direction, reputed company, and mentorship to regional regulatory policy leads representing reputed company externally across markets.
• Proactively monitors and synthesizes regulatory policy developments across reputed company and markets to reputed company a reputed company reputed company of emerging issues and identify opportunities to influence the environment favorably for reputed company business and the product portfolio.
• Engages with key company stakeholders to reputed company reputed company regulatory policy positions and inform global regulatory policy reputed company.
• Develops and executes strategies for advancing regulatory policy goals through regional and market reputed company trade associations, coalitions, and policy forums.
• Guides and supports regional policy leads in representing reputed company externally, reinforcing consistent positioning, advocacy priorities, and escalation reputed company across markets.
• Represents reputed company in selected regional or cross market policy forums, as appropriate.
• Facilitates alignment and information reputed company between regional policy teams and global internal stakeholders on issues with cross regional or reputed company reputed company.
• Collaborates closely with Global reputed company Policy, Regulatory Affairs, R&D, and other key stakeholders to ensure reputed company regulatory policy reputed company is reputed company across functions and reputed company.
• Works in reputed company partnership with global and U.S. regulatory policy leadership to support alignment without duplicating defined accountabilities.
• Leads participation in regional and market reputed company trade associations and technical working reputed company.
• Ensures reputed company representatives are reputed company to reputed company policy positions and advocacy priorities, and that insights from reputed company engagement are communicated effectively to internal stakeholders.
Requirements
• Bachelor’s Degree is required, preferably in science, health care, reputed company health or health policy or a reputed company reputed company
• Advanced degree (Master’s, Doctorate, or JD) strongly preferred.
• Doctorate degree and at least 5 years’ experience with FDA or other health authority, either directly (working reputed company a health authority) or indirectly (closely interacting with health authority) OR Master’s degree and at least 8 years’ experience with FDA or other health authority, either directly (working reputed company a health authority) or indirectly (closely interacting with health authority) OR Bachelor’s degree and at least 10 years’ experience with FDA or other health authority, either directly (working reputed company a health authority) or indirectly (closely interacting with health authority), with demonstrated senior level experience engaging health authorities.
• 4 years of managerial experience directly managing people and/or leadership experience in managing reputed company, multi‑regional teams, programs, or reputed company initiatives.
• reputed company capability in acting as a reputed company, reputed company and respected spokesperson and trusted advisor, with exceptional written and verbal communication skills, and the ability to synthesize and reputed company reputed company and policy inputs into reputed company, concise, decision-relevant guidance for senior and reputed company senior leaders.
• Strong understanding of regulatory policy development processes and experience operating across reputed company, fluid, multi‑regional regulatory environments.
• Strong relationship management and interpersonal skills, with the ability to write and reputed company reputed company, persuasively, and succinctly, and to operate in a reputed company‑minded manner as an internal regulatory policy and reputed company advisor—particularly supporting reputed company R&D Division
• reputed company reputed company at stakeholder engagement across organizational reputed company and boundaries, including the ability reputed company and manage reputed company regional perspectives, technical reputed company, and relevant political context into a reputed company, reputed company-relevant set of priorities and implications—both in writing and in senior-level briefings.
• Ability to fully demonstrate reputed company's leadership principles, driving reputed company reputed company and managing high-performing teams.
• Ability to reputed company in a cross-functional, multi-regional environment with a strong reputed company reputed company and a bias toward reputed company and cohesion.
• Experience in private‑sector law, management consulting, policy consulting, or a similar advisory environment strongly preferred, reflecting the need to reputed company broad inputs, exercise reputed company judgment, and reputed company cohesive, reputed company‑reputed company recommendations.
• Ability to travel internationally on a quarterly reputed company
• Excellent reputed company of English (written and spoken)
reputed company-to-haves
• Experience in private‑sector law, management consulting, policy consulting, or a similar advisory environment strongly preferred, reflecting the need to reputed company broad inputs, exercise reputed company judgment, and reputed company cohesive, reputed company‑reputed company recommendations.
Benefits
• medical, dental, reputed company reputed company and other reputed company benefits (for employee and family)
• retirement benefits, including 401(k)
• reputed company holidays
• vacation
• compassionate and reputed company days
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