Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity

Role Summary

Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity. Develop and implement global regulatory strategies for assigned products, lead a Global Regulatory Team, and ensure alignment with global and regional objectives to support lifecycle management and commercial goals.

Responsibilities

• Develop, update, and implement the Global Regulatory Strategy (RSD) for assigned programs, including devices where applicable, integrated from Candidate Selection through End of Product Lifecycle.
• Lead the Global Regulatory Team to create robust regulatory strategies, leveraging scientific development knowledge and regulatory precedents; incorporate external information and regulator advice.
• Provide input for and attend key regulatory agency meetings that could impact global strategy or brand; facilitate discussions of RSD and regulatory issues at the Regulatory Strategy Forum.
• Expand therapeutic area knowledge; monitor global regulations and guidance; track approvals of competitive programs.
• Ensure strategic messaging and content of global regulatory submissions; guide core data sheet and claims mapping to align with commercial objectives and data availability.
• Ensure local regulatory strategies deliverables align with global strategy and BU/brand goals; communicate updates to GBD teams and internal stakeholders.
• Lead the Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling and Product Communications); maintain clear two-way communication with GBD/global program teams.
• Coach and foster high performance within the Global Regulatory Team; share knowledge to enable seamless execution of strategy and cross-functional learning.
• Represent Regulatory on GBD/Global Program Team; support development planning, trial design, and registration strategies across in-scope countries, involving necessary regulatory scientists.
• Communicate well-defined regulatory strategies across the organization; engage external environment initiatives related to portfolio assets; build strategic external relationships.
• Review corporate press releases; coordinate with Global Marketing and GBD on promotional claims; partner with Regulatory Product Communications to advise on strategy and approve press materials and IR communications.

Qualifications

• Advanced scientific degree (PhD, PharmD) with 8+ years of industry experience in regulatory affairs and/or drug development; or Bachelor's degree with 10+ years of experience.

Skills

• Strategic regulatory planning and leadership; ability to develop innovative regulatory strategies and accelerate timelines.
• Strong communication and cross-functional collaboration; ability to influence at executive levels.
• Regulatory submissions experience across US, EU, China, and Japan; capability to manage global regulatory programs.
• Risk assessment and management within a highly regulated environment; negotiation and stakeholder management.
• Travel willingness (approximately 10-15%).

Education

• Advanced scientific degree (PhD, PharmD) or equivalent with relevant regulatory experience.

Additional Requirements

• Proven leadership with bold, effective communication; conflict management skills; ability to manage multiple country programs.
• Experience with regulatory submissions and interactions in multiple regions; direct experience in clinical and CMC regulatory sciences; knowledge of Global regulatory procedures and evolving reforms.
• Ability to foster inclusive, collaborative environments; strong written, spoken, and presentation skills.
• Preference for Therapeutic area experience in diabetes/obesity; relocation to Indianapolis provided.