Senior Director Global Regulatory Lead - Oncology
Eli Lilly and Company
2 months ago
Remote friendly (Indiana, United States)
United States
Corporate Functions
Purpose
- Develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area, ensuring strategies meet global business objectives and regional/local affiliate requirements.
Primary Responsibilities
Regulatory and Scientific Expertise (Develop/Update/Execute Global Regulatory Strategy)
- Develop and execute global regulatory strategy integrated into the development team plan from Candidate Selection to End of Product Lifecycle (including NILEX).
- Lead development of Regulatory Strategy Document(s) (RSDs) for assigned programs; initiate and maintain RSDs using team expertise, scientific/drug/device development knowledge, and regulatory policies/precedents/trends/emerging science.
- Integrate external environment inputs and public information (e.g., Advisory Committees) to develop robust strategies.
- Provide input for and attend key regulatory agency meetings as needed.
- Enable RSD and regulatory issue/challenge discussions in the Regulatory Strategy Forum.
- Maintain therapeutic area knowledge; monitor global regulations/guidance and competitive approvals.
- Ensure strategic messaging/content of global regulatory submission documents, including direction for core data sheet and claims mapping.
- Ensure local strategies/solutions deliver against global regulatory strategy and meet BU and brand goals; provide timely updates to GBD, BU leadership, and internal stakeholders.
Lead Global Regulatory Team
- Lead global regulatory team (regional regulatory scientists; GRA-CMC; GRA-Devices; GRA-RD&E; GRA-Global Labeling and Product Communications).
- Ensure two-way communication between GBD/global program team and Global Regulatory Team.
- Coach/facilitate feedback culture; share key information for seamless execution and cross-functional learnings.
Represent Regulatory on GBD/Global Program Team
- Support strategic planning, trial design, and registration strategies for in-scope countries for assigned products/programs.
- Communicate successful regulatory strategies throughout the organization.
Preclinical/Early Clinical: US Strategy (IND/IDE)
- Lead and develop US strategy for submission and amendments for IND and IDE.
- Determine and communicate submission/approval requirements and regulator expectations.
- Generate regulatory documents aligned with regulator expectations and clearly articulating Lilly’s scientific position.
- Anticipate/resolve/communicate technical, operational, and strategic issues impacting development.
- Propose compliant solutions that meet business objectives while maintaining internal quality systems.
- Own US FDA relationship and interaction strategy; execute communications to FDA and internal stakeholders; accountable for regulator and cross-functional communications.
External Environment / Portfolio Assets
- Create and foster strategic relationships with key external players to identify and anticipate growth opportunities.
Promotional Claims / Press Materials
- Set direction with Global Marketing and GBD for development/review/approval of promotional claims.
- Partner with Regulatory Product Communications to advise on promotional strategy and review/approve press and IR communications.
Lead/Influence/Partner
- Exemplify Team Lilly behaviors (Include, Innovate, Accelerate, Deliver); model regulatory excellence and leadership behaviors.
- Participate in forums sharing regulatory information; constructively challenge teams to reach best solutions.
- Mentor GRA personnel; may have direct reports.
Qualifications
Minimum
- Advanced scientific degree (PhD, PharmD) and 8+ years industry experience in regulatory affairs and/or drug development.
- OR Bachelor’s degree and 10+ years industry experience in regulatory affairs and/or drug development.
Preferred / Additional
- Leadership experience with bold leadership, effective communications, and conflict management.
- Travel: 10–15%.
- Experience with regulatory submissions/interactions in US, EU, China, and Japan; prior cross-country regulatory/leadership assignments.
- 10+ years industry regulatory affairs/drug development experience; direct experience in clinical and CMC regulatory sciences.
- Experience in applicable therapeutic area; knowledge of global regulatory procedures and evolving regulatory reform initiatives.
- Deep knowledge of integrated drug development process and regulatory/business strategies.
- Ability to assess/manage risk; strong written/spoken/presentation communication; negotiation and influence skills; attention to detail.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
- Develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area, ensuring strategies meet global business objectives and regional/local affiliate requirements.
Primary Responsibilities
Regulatory and Scientific Expertise (Develop/Update/Execute Global Regulatory Strategy)
- Develop and execute global regulatory strategy integrated into the development team plan from Candidate Selection to End of Product Lifecycle (including NILEX).
- Lead development of Regulatory Strategy Document(s) (RSDs) for assigned programs; initiate and maintain RSDs using team expertise, scientific/drug/device development knowledge, and regulatory policies/precedents/trends/emerging science.
- Integrate external environment inputs and public information (e.g., Advisory Committees) to develop robust strategies.
- Provide input for and attend key regulatory agency meetings as needed.
- Enable RSD and regulatory issue/challenge discussions in the Regulatory Strategy Forum.
- Maintain therapeutic area knowledge; monitor global regulations/guidance and competitive approvals.
- Ensure strategic messaging/content of global regulatory submission documents, including direction for core data sheet and claims mapping.
- Ensure local strategies/solutions deliver against global regulatory strategy and meet BU and brand goals; provide timely updates to GBD, BU leadership, and internal stakeholders.
Lead Global Regulatory Team
- Lead global regulatory team (regional regulatory scientists; GRA-CMC; GRA-Devices; GRA-RD&E; GRA-Global Labeling and Product Communications).
- Ensure two-way communication between GBD/global program team and Global Regulatory Team.
- Coach/facilitate feedback culture; share key information for seamless execution and cross-functional learnings.
Represent Regulatory on GBD/Global Program Team
- Support strategic planning, trial design, and registration strategies for in-scope countries for assigned products/programs.
- Communicate successful regulatory strategies throughout the organization.
Preclinical/Early Clinical: US Strategy (IND/IDE)
- Lead and develop US strategy for submission and amendments for IND and IDE.
- Determine and communicate submission/approval requirements and regulator expectations.
- Generate regulatory documents aligned with regulator expectations and clearly articulating Lilly’s scientific position.
- Anticipate/resolve/communicate technical, operational, and strategic issues impacting development.
- Propose compliant solutions that meet business objectives while maintaining internal quality systems.
- Own US FDA relationship and interaction strategy; execute communications to FDA and internal stakeholders; accountable for regulator and cross-functional communications.
External Environment / Portfolio Assets
- Create and foster strategic relationships with key external players to identify and anticipate growth opportunities.
Promotional Claims / Press Materials
- Set direction with Global Marketing and GBD for development/review/approval of promotional claims.
- Partner with Regulatory Product Communications to advise on promotional strategy and review/approve press and IR communications.
Lead/Influence/Partner
- Exemplify Team Lilly behaviors (Include, Innovate, Accelerate, Deliver); model regulatory excellence and leadership behaviors.
- Participate in forums sharing regulatory information; constructively challenge teams to reach best solutions.
- Mentor GRA personnel; may have direct reports.
Qualifications
Minimum
- Advanced scientific degree (PhD, PharmD) and 8+ years industry experience in regulatory affairs and/or drug development.
- OR Bachelor’s degree and 10+ years industry experience in regulatory affairs and/or drug development.
Preferred / Additional
- Leadership experience with bold leadership, effective communications, and conflict management.
- Travel: 10–15%.
- Experience with regulatory submissions/interactions in US, EU, China, and Japan; prior cross-country regulatory/leadership assignments.
- 10+ years industry regulatory affairs/drug development experience; direct experience in clinical and CMC regulatory sciences.
- Experience in applicable therapeutic area; knowledge of global regulatory procedures and evolving regulatory reform initiatives.
- Deep knowledge of integrated drug development process and regulatory/business strategies.
- Ability to assess/manage risk; strong written/spoken/presentation communication; negotiation and influence skills; attention to detail.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation