Sr. Director - Global Regulatory Lead - Neuroscience/Immunology

Role Summary

The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable decision maker for the development and execution of global regulatory strategies from portfolio entry to end of life cycle to ensure strategies meet global business objectives and regional/local affiliate requirements. The GRL creates and leads the Global Regulatory Team and is responsible for forming and maintaining a highly effective global regulatory team, the creation and maintenance of the Regulatory Strategy Document, and alignment of local plans with Global Brand Development and global program priorities. For preclinical and early clinical development programs, the GRL leads the US and Canada submissions and agency interactions; other agency interactions fall to regional regulatory scientists.

Responsibilities

• Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)
• Obtain input from the global regulatory team to develop a global regulatory strategy supporting product development, registration, and lifecycle maintenance globally; integrate strategy into the development plan; drive acceleration strategies and communicate regulatory risks
• Lead Global Regulatory Team in the development of RSDs; leverage team expertise and regulatory knowledge to create robust strategies
• Provide input for and attend key regulatory agency meetings as needed
• Enable discussion of the RSD and regulatory issues at the Regulatory Strategy Forum with the Global Regulatory Team
• Monitor regulatory environment and therapeutic area knowledge; assess impact of regulations and approvals of competitors
• Ensure strategic messaging and content of global regulatory submission documents; guide core data sheet and claims mapping to align commercial objectives with data and guidance
• Ensure local strategies align with global regulatory strategy and business goals; communicate updates to GBD teams and management

• Lead Global Regulatory Team
• Lead a team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications; ensure clear two-way communication between GBD/global program team and Global Regulatory Team
• Coach and facilitate a feedback culture; promote performance and knowledge sharing

• Represent Regulatory on the GBD/Global Program Team
• Support development teams in strategic planning, trial design and registration strategies for all in-scope countries; bring in regional CMC and Device regulatory scientists as needed
• Communicate well-defined regulatory strategies throughout the organization

• For Preclinical and Early Clinical Development Programs: Lead US/Canada strategy for IND, IDE, CTA submissions and amendments
• Determine submission/approval requirements and regulator expectations; generate regulatory documents with appropriate data to articulate Lilly’s scientific position
• Anticipate and resolve key issues affecting other functions; propose innovative solutions to meet objectives while maintaining compliance
• Own relationship and interaction strategy with US/Canada regulatory authorities; build and leverage relationships with FDA, Health Canada, teams, and partners
• Communicate regulatory strategy and complex issues to regulators and internal stakeholders

• Engage in external environment initiatives related to portfolio assets
• Foster strategic relationships with key external players to identify opportunities for growth

• Review corporate communications and press releases
• Set direction with Global Marketing and GBD for promotional claims; partner with Regulatory Product Communications reviewer for promotional strategy and press/IR materials

• Lead/Influence/Partner
• Model leadership behaviors; mentor GRA personnel; may have direct reports

Qualifications

• Required: Advanced scientific degree (PhD, PharmD) and 8+ years of industry-related regulatory affairs and/or drug development experience
• Required: OR Bachelor’s degree with 10+ years of industry-related regulatory affairs and/or drug development experience
• Preferred: Experience in regulatory submissions and interactions across US, EU, China, and Japan; direct experience in clinical and CMC regulatory sciences; experience in neuroscience and/or immunology
• Preferred: Travel 10-15%; based in Indianapolis, IN; relocation may be provided
• Required/Preferred: Global regulatory procedures knowledge; ability to manage risk in a highly regulated environment; strong written, spoken and presentation communication; negotiation and influence skills
• Preferred: Demonstrated leadership, boldness, strategic thinking, and ability to work with diverse teams

Education

• Advanced scientific degree (PhD, PharmD) or equivalent clinical/regulatory knowledge

Additional Requirements

• Travel expected (10-15%)