Sr. Director - Global Regulatory Lead - Neuroscience/Immunology

Role Summary

Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role to develop and implement global regulatory strategies for products in neuroscience/immunology. Responsible for leading the Global Regulatory Team, creating and maintaining Regulatory Strategy Documents, aligning local plans with global priorities, and representing regulatory input to global program teams. For preclinical and early clinical programs, leads US/Canada submissions and agency interactions.

Responsibilities

• Develop, Update and Execute the Global Regulatory Strategy; initiate and maintain Regulatory Strategy Documents (RSDs) for assigned programs; integrate regulatory strategy into development plans and lifecycle management.
• Lead Global Regulatory Team, ensuring clear two-way communication with the global program team and cross-functional groups; coach and develop team performance.
• Represent Regulatory on the GBD/Global Program Team; support strategic planning, trial design, and registration strategies across in-scope countries; communicate regulatory strategies throughout the organization.
• For Preclinical and Early Clinical Development Programs: lead US/Canada strategy for IND/IDE/CTA submissions; determine regulatory requirements; prepare regulatory documents; manage regulator interactions; own communications with regulators and internal stakeholders.
• Engage external environment initiatives related to portfolio assets; build strategic relationships with key external stakeholders.
• Coordinate with Global Marketing and GBD for promotional claims; advise on promotional strategy and approve press/IR communications in collaboration with regulatory product communications.
• Lead/Influence/Partner: mentor GRA personnel; foster a culture of innovation and collaboration; may have direct reports.

Qualifications

• Advanced scientific degree (PhD or PharmD) with 8+ years of industry-related regulatory affairs and/or drug development experience, or a Bachelor's degree with 10+ years of experience.
• Experience in regulatory submissions and interactions in the US, EU, China, and Japan; leadership experience across multiple countries; direct experience in clinical and CMC regulatory sciences.

Skills

• Strong regulatory strategy development and execution; ability to lead global teams and drive cross-functional collaboration.
• Excellent written, verbal, and presentation communication; negotiation and influence skills; risk assessment and mitigation.
• Relationship management with regulators (FDA, Health Canada, etc.) and external partners; ability to articulate complex regulatory strategies clearly.

Education

• Advanced scientific degree (PhD, PharmD) or equivalent; relevant regulatory affairs education or certifications desirable.

Additional Requirements

• Travel expected (10-15%).
• Location: Indianapolis, IN; relocation provided.