Sr. Director-Global Regulatory Affairs-North America

Company: Eli Lilly Company
Location: Indianapolis
Posted on: May 27, 2023

Job Description:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Sr. Director, GRA-NA Regulatory Scientist

Organization Overview:

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.

Purpose:

The purpose of the Sr. Director, Regulatory Scientist role is to provides leadership and oversight to deliver US and Canada regulatory strategies and win through regulatory for assigned assets.The Regulatory Scientist partners across Lilly teams, partner companies, and health authorities to enable market differentiation of first-in-class/best-in-class assets.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Responsibilities:

Develop, Update and Execute US and Canada Registration Strategy

Initiate and Update Regulatory Strategy Document

• Initiate and update regulatory strategy documents by leveraging scientific, drug/device clinical development and knowledge from FDA/HC meetings and regulatory trends. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies.
• Review, summarize, and present information regarding regulator expectations by utilizing agency feedback received by Lilly and knowledge of competitor labelling.
• Monitor upcoming and recent approvals of competitive development programs/plans
• Integrate US/CA regulatory strategy into global registration strategy
• Serve as global regulatory coordinator as assigned by GRA management.
• Partner with colleagues across regulatory functions to deliver integrated US/Canada regulatory strategy
• Communicate and share key information to enable seamless execution of US/Canada regulatory strategy
  
  Provide input to clinical program to support market differentiation needs
  
  • Communicate the regulatory options and impact on proposed product development plans.
  • Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation of first-in-class/best-in-class assets.
    • Collaborate with PRA and GPO-RWE for the success of the pricing and access strategies through influencing what data is needed and how it is collected on development or product lifecycle planning
      
      Lead development and update of labeling strategy to deliver market differentiation
      
      Initiate and update Target Product Profile, Claims Mapping, and Labeling Dashboard
      
      • Partner with regulatory, product and clinical development, commercial and project personnel to drive a Market Differentiation as Driver Strategy using available tools and resources (e.g., TPP, Claims mapping) and network for alignment.Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.Use global labelling strategy to influence the drug development strategy, as needed.
      • Create and communicate labeling dashboard to drive internal alignment on labeling strategy and key risks.
        
        Develop and Update US and CA labeling, including prescribing information, patient labeling, device labeling (IFU) for new products and indications
        
        • Lead the development of the US/Canadian labelling strategy in collaboration with other regulatory and project personnel and network for alignment across affiliate labelling team to enable timely completion of US/Canadian product (drug and device) registration milestones (submission, approval and launch).
        • Lead strategic development of US/CA labelling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and provide responses to agency labelling questions. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling.
          
          Lead and develop the strategy for submission and amendments for: IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novo
          
          • Determine and communicate submission and approval requirements and regulator expectations
          • Generate regulatory documents for medium to high complexity submissions.Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are clearly written to articulate Lilly's scientific position.
          • Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact the MDU function or the development team.
          • Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems.
            
            Primary liaison with product and clinical development team and liaison with diagnostic development experts
            
            • Provide high quality, timely and decisive regulatory advice that enables business partners to make well-informed decisions on development of drugs, diagnostics, devices, and product lifecycle planning and business development
            • Communicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory management
            • Cultivate relationships with development teams and leadership.
              
              Liaison with global marketing/NPP/HO/GPORWE/Payer functions/US Brand Teams
              
              • Contribute to global and US launch-readiness plan and connect commercial partners (global marketing/NPP/GPORWE/Payer functions/US Brand Teams) with development teams to drive market differentiation strategy for assigned assets, including labelling and promotional deliverables throughout the product lifecycle
              • Cultivate relationships with global marketing/NPP/HO/GPORWE/Payer functions/US Brand Teams and US/Canadian affiliate leadership.
                
                Own relationship and interaction strategy with US and Canada regulatory authorities
                
                • Build, maintain, and leverage relationships with FDA, Health Canada, team members, and partner companies as appropriate.
                • Execute high quality communications with FDA, Health Canada and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues.
                • Accountable for communications to the regulator, development teams, and GRA, MDU, Research, and BU leadership.
                  
                  Engage in, influence, and shape external environment initiatives related to portfolio assets
                  
                  • Creates and fosters strategic relationship with key external players to identify and anticipate opportunities for growth.This may include FDA, external regulatory experts, academic thought leaders, and industry groups.
                    
                    Advise/Approve US promotional strategy and claims
                    
                    Review corporate communications press releases and social media posts
                    
                    • Set appropriate direction with Global Marketing and US Brand Team for development, review and approval of promotional claims
                    • Partner with Regulatory Ad/Promo reviewer to advise US Brand Team on promotional strategy
                    • Partner with Regulatory Ad/Promo reviewer to review and approve press materials and IR communications.
                      
                      Lead/Influence/Partner
                      
                      • Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions
                      • Model the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
                      • Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners
                      • Constructively challenge teams to reach the best solutions to issues
                      • Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions
                      • Serve as a mentor for GRA-NA personnel and others in GRA
                        
                        Basic Qualifications:
                        
                        • Bachelor's degree in a science related field
                        • Minimum of 5 years industry-related experience in regulatory affairs and/or drug development
                          
                          Additional Preferences:
                          
                          • Advanced scientific degree (i.e., PhD, MD, PharmD) strongly preferred
                          • Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable
                          • Demonstrated deep knowledge of the drug development process, Lilly regulatory/business strategies and plans required
                          • Demonstrated ability to assess and manage risk in a highly regulated environment
                          • Demonstrated strong written, spoken and presentation communication
                          • Demonstrated negotiation and influence skills
                          • Demonstrated attention to detail
                          • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
                            
                            Additional Information:
                            
                            • Travel expected (10-15%)
                              
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Keywords: Eli Lilly Company, Indianapolis , Sr. Director-Global Regulatory Affairs-North America, Executive , Indianapolis, Indiana