Eli Lilly and Company · 1 day ago
Sr. Director - Global Regulatory Lead - Neuroscience/Immunology
Indianapolis, IN
Full-time
Onsite
Director/Executive
$170K/yr - $275K/yr
8+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving the lives of people around the world. They are seeking a Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) to develop and implement innovative global regulatory strategies for products in the neuroscience and immunology therapeutic areas.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD) Obtain input from the global regulatory team members to develop a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance globally. Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecyle (including NILEX). Develop and implement innovative approaches and solutions, and drive acceleration strategies. Identify and effectively communicate regulatory risks
Lead Global Regulatory Team in the development of RSD(s) for assigned programs. Initiate and maintain regulatory strategy documents by leveraging team expertise, as well as scientific, drug/device clinical development and knowledge from health authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory science. Integrate information from the external environment, product specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies and solutions
Provide input for and attend key regulatory agency meetings, as needed, that could impact the global product strategy or brand
Enable discussion of the RSD and regulatory issues/challenges at the Regulatory Strategy Forum together with Global Regulatory Team
Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment. Monitor upcoming and recent approvals of competitive development programs/plans
Ensure strategic messaging and content of global regulatory submission documents. Provide regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Ensures local strategies and solution deliver to the global regulatory strategy and meets business and brand goals
Provide timely and effective communication updates to the GBD teams and business management and other internal stakeholders, as appropriate
Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensures clear and transparent two-way communication between GBD/global program team and Global Regulatory Team
Coach and facilitate a feedback culture within the Global Regulatory Team to develop team performance
Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings
Support development teams in strategic planning, trial design and registration strategies for all in-scope countries for assigned products/programs, bringing in regional, CMC and Device regulatory scientists as needed
Consistently communicate well defined, successful regulatory strategies throughout the organization
Lead and develop the US and Canada strategy for submission and amendments for IND, IDE, CTA Determine and communicate submission and approval requirements and regulator expectations
Generate regulatory documents and 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 other development functions or the development team
Propose innovative solutions to regulatory issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems
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, GRA, other development functions, Research, and BU leadership
Creates and fosters strategic relationship with key external players to identify and anticipate opportunities for growth
Set appropriate direction with Global Marketing and GBD team for development, review, and approval of promotional claims
Partner with Regulatory Product Communications reviewer to advise GBD team on promotional strategy
Partner with Regulatory Product Communications reviewer to review and approve press materials and IR communications
Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions
Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers
Constructively challenge teams to reach the best solutions to issues
Serve as a mentor for GRA personnel
May have direct reports
Qualification
Required
Advanced scientific degree (i.e., PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience
Bachelor's degree with 10+ years of industry-related experience in regulatory affairs and/or drug development experience
Proven experiences and leadership assignments demonstrating bold leadership, exemplary team attributes, effective communications with peers and executive leaders, and effective conflict management skills
Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
Demonstrated deep knowledge of the integrated drug development process and Lilly's (or external peer company) regulatory/business strategies
Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes
Demonstrated ability to assess and manage risk in a highly regulated environment
Strong written, spoken and presentation communication
Demonstrated negotiation and influence skills
Demonstrated attention to detail
Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan
Previous regulatory or leadership assignments across multiple countries
Industry-related experience in regulatory affairs and/or drug development experience for 10 years
Direct experience in clinical and CMC regulatory sciences
Experience in applicable therapeutic area neuroscience and/or immunology
Travel expected (10-15%)
Benefits
Company bonus
401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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