Sr. Director - Global Regulatory Lead - Neuroscience/Immunology
Eli Lilly and Company
12 hours ago
On-site
Indianapolis, IN
$169,500 - $248,600 USD yearly
Corporate Functions
Purpose
- Develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area.
- Accountable decision maker for development and execution of global regulatory strategies from portfolio entry through end of life cycle to meet global business objectives and regional/local affiliate requirements.
Primary Responsibilities
- Develop, update, and implement global regulatory strategy and Regulatory Strategy Document (RSD) for assigned programs.
- Obtain global regulatory team input to support global product development, registration, and lifecycle maintenance (including delivery devices and relevant medical devices).
- Lead RSD(s) development using scientific knowledge, regulatory policies/precedents, trends, and emerging regulatory science.
- Integrate external environment, regulator advice, and public information (e.g., Advisory Committees) to create robust regulatory strategies.
- Identify, communicate, and manage regulatory risks.
- Provide input for and attend key regulatory agency meetings that may impact global product strategy/brand.
- Enable discussion of RSD and regulatory issues/challenges at the Regulatory Strategy Forum.
- Monitor therapeutic area knowledge, global regulations/guidance, and competitive approvals.
- Ensure strategic messaging and content of global regulatory submission documents; direct core data sheet and claims mapping aligned to scientific data, guidance, and precedent.
- Ensure local strategies align to global regulatory strategy and business/brand goals.
- Provide timely communication updates to GBD teams and internal collaborators.
- Lead the Global Regulatory Team.
- Lead and maintain an effective team (regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, GRA-Global Labeling and Product Communications).
- Ensure clear two-way communication with GBD/global program teams.
- Coach and facilitate a feedback culture and develop team performance.
- Share key information to enable seamless execution and cross-functional alignment.
- Represent Regulatory on the GBD/Global Program Team.
- Support strategic planning, trial design, and registration strategies across in-scope countries.
- Communicate successful regulatory strategies throughout the organization.
- Preclinical/Early Clinical Programs (US/Canada).
- Lead US and Canada strategy for submissions and amendments for IND, IDE, and CTA.
- Determine and communicate submission/approval requirements and regulator expectations.
- Generate regulatory documents that clearly articulate Lilly’s scientific position with regulator-expected data.
- Anticipate, resolve, and communicate key technical/operational/strategic issues impacting development functions.
- Propose innovative, compliant solutions aligned to business objectives and internal quality systems.
- Own US/Canada regulatory authority relationship and interaction strategy.
- Build/maintain/ leverage relationships with FDA, Health Canada, team members, and partners as appropriate.
- Execute high-quality communications with regulators and internal customers; ensure regulator and stakeholder understanding.
- Accountable for communications to the regulator, development teams, GRA, other development functions, Research, and BU leadership.
- Engage in external environment initiatives related to portfolio assets.
- Create and foster strategic relationships with key external players to identify and anticipate growth opportunities.
- Promotional/communications collaboration.
- Set direction with Global Marketing/GBD on development, review, and approval of promotional claims.
- Partner with Regulatory Product Communications to advise on promotional strategy and review/approve press materials and IR communications.
- Lead/Influence/Partner.
- Exemplify Team Lilly behaviors (Include, Innovate, Accelerate, Deliver).
- Constructively challenge teams to reach best solutions.
- Mentor GRA personnel; may have direct reports.
Minimum Qualification Requirements
- Advanced scientific degree (PhD or PharmD) with 8+ years of industry experience in regulatory affairs and/or drug development.
OR
- Bachelor’s degree with 10+ years of industry experience in regulatory affairs and/or drug development.
Preferred/Additional Qualifications & Skills
- Proven leadership and leadership assignments; effective communication with peers and executive leaders; conflict management.
- Knowledge of global regulatory procedures/practices; awareness of evolving regulatory reform initiatives.
- Deep knowledge of integrated drug development process and regulatory/business strategies.
- Ability to find solutions and alternatives through teamwork (including diversity, equity, and inclusion).
- Ability to assess and manage risk in a highly regulated environment.
- Strong written, spoken, and presentation communication.
- Negotiation and influence skills; attention to detail.
- Experience with regulatory submissions and regulatory interactions in the US, EU, China, and Japan.
- Previous regulatory/leadership experience across multiple countries.
- Direct experience in clinical and CMC regulatory sciences.
- Experience in therapeutic area neuroscience and/or immunology.
- Travel expected (10–15%).
- Based in Indianapolis, IN; relocation provided.
Benefits (as stated)
- Company bonus (for full-time equivalent employees, depending on company and individual performance).
- Comprehensive benefits for eligible employees: company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits (e.g., healthcare and/or dependent day care FSA), life insurance/death benefits, time off and leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
- Anticipated wage: $169,500–$248,600.
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.
- Accountable decision maker for development and execution of global regulatory strategies from portfolio entry through end of life cycle to meet global business objectives and regional/local affiliate requirements.
Primary Responsibilities
- Develop, update, and implement global regulatory strategy and Regulatory Strategy Document (RSD) for assigned programs.
- Obtain global regulatory team input to support global product development, registration, and lifecycle maintenance (including delivery devices and relevant medical devices).
- Lead RSD(s) development using scientific knowledge, regulatory policies/precedents, trends, and emerging regulatory science.
- Integrate external environment, regulator advice, and public information (e.g., Advisory Committees) to create robust regulatory strategies.
- Identify, communicate, and manage regulatory risks.
- Provide input for and attend key regulatory agency meetings that may impact global product strategy/brand.
- Enable discussion of RSD and regulatory issues/challenges at the Regulatory Strategy Forum.
- Monitor therapeutic area knowledge, global regulations/guidance, and competitive approvals.
- Ensure strategic messaging and content of global regulatory submission documents; direct core data sheet and claims mapping aligned to scientific data, guidance, and precedent.
- Ensure local strategies align to global regulatory strategy and business/brand goals.
- Provide timely communication updates to GBD teams and internal collaborators.
- Lead the Global Regulatory Team.
- Lead and maintain an effective team (regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, GRA-Global Labeling and Product Communications).
- Ensure clear two-way communication with GBD/global program teams.
- Coach and facilitate a feedback culture and develop team performance.
- Share key information to enable seamless execution and cross-functional alignment.
- Represent Regulatory on the GBD/Global Program Team.
- Support strategic planning, trial design, and registration strategies across in-scope countries.
- Communicate successful regulatory strategies throughout the organization.
- Preclinical/Early Clinical Programs (US/Canada).
- Lead US and Canada strategy for submissions and amendments for IND, IDE, and CTA.
- Determine and communicate submission/approval requirements and regulator expectations.
- Generate regulatory documents that clearly articulate Lilly’s scientific position with regulator-expected data.
- Anticipate, resolve, and communicate key technical/operational/strategic issues impacting development functions.
- Propose innovative, compliant solutions aligned to business objectives and internal quality systems.
- Own US/Canada regulatory authority relationship and interaction strategy.
- Build/maintain/ leverage relationships with FDA, Health Canada, team members, and partners as appropriate.
- Execute high-quality communications with regulators and internal customers; ensure regulator and stakeholder understanding.
- Accountable for communications to the regulator, development teams, GRA, other development functions, Research, and BU leadership.
- Engage in external environment initiatives related to portfolio assets.
- Create and foster strategic relationships with key external players to identify and anticipate growth opportunities.
- Promotional/communications collaboration.
- Set direction with Global Marketing/GBD on development, review, and approval of promotional claims.
- Partner with Regulatory Product Communications to advise on promotional strategy and review/approve press materials and IR communications.
- Lead/Influence/Partner.
- Exemplify Team Lilly behaviors (Include, Innovate, Accelerate, Deliver).
- Constructively challenge teams to reach best solutions.
- Mentor GRA personnel; may have direct reports.
Minimum Qualification Requirements
- Advanced scientific degree (PhD or PharmD) with 8+ years of industry experience in regulatory affairs and/or drug development.
OR
- Bachelor’s degree with 10+ years of industry experience in regulatory affairs and/or drug development.
Preferred/Additional Qualifications & Skills
- Proven leadership and leadership assignments; effective communication with peers and executive leaders; conflict management.
- Knowledge of global regulatory procedures/practices; awareness of evolving regulatory reform initiatives.
- Deep knowledge of integrated drug development process and regulatory/business strategies.
- Ability to find solutions and alternatives through teamwork (including diversity, equity, and inclusion).
- Ability to assess and manage risk in a highly regulated environment.
- Strong written, spoken, and presentation communication.
- Negotiation and influence skills; attention to detail.
- Experience with regulatory submissions and regulatory interactions in the US, EU, China, and Japan.
- Previous regulatory/leadership experience across multiple countries.
- Direct experience in clinical and CMC regulatory sciences.
- Experience in therapeutic area neuroscience and/or immunology.
- Travel expected (10–15%).
- Based in Indianapolis, IN; relocation provided.
Benefits (as stated)
- Company bonus (for full-time equivalent employees, depending on company and individual performance).
- Comprehensive benefits for eligible employees: company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits (e.g., healthcare and/or dependent day care FSA), life insurance/death benefits, time off and leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
- Anticipated wage: $169,500–$248,600.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation