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 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.
Purpose:
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 & 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 (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists) and is responsible for forming and maintaining a highly effective global regulatory team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional regulatory teams, are aligned to the Global Brand Development (GBD)/global program team and business priorities in terms of the program’s value proposition, workflow, product labeling, risk management, and issues management. Accordingly, the GRL is the primary interface with and will represent GRA on GBD/global program team to ensure global input into development plans, provide solutions (created with the regulatory team) to development and regulatory barriers, and reflect and manage risks. The GRL will represent regional regulatory plans to the GBD/global program team and at stakeholder/governance meetings and is responsible to include GRA functional and regional experts as needed to inform development and manage issues.
For preclinical and early clinical development programs, the GRL leads the US submissions and agency interactions. All other agency interactions will be the responsibility of the regional regulatory scientists.
Primary Responsibilities:
Regulatory and Scientific Expertise
_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 BU and brand goals.
- Provide timely and effective communication updates to the GBD teams and BU management and other internal stakeholders, as appropriate.
Lead Global Regulatory Team
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.
Represent Regulatory on the GBD/Global Program Team
- 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.
For Preclinical and Early Clinical Development Programs: Lead and develop the US strategy for submission and amendments for IND and IDE
- 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 FDA
- Execute high quality communications with FDA and internal stakeholders 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.
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.
Review corporate communications press releases
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.
Lead/Influence/Partner
- 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.
- 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.
- Serve as a mentor for GRA personnel.
- May have direct reports.
**Minimum Qualification Requirements: **
- Advanced scientific degree (i.e., PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience
OR
- Bachelor’s degree with 10+ years of industry-related experience in regulatory affairs and/or drug development experience
**Other Information/Additional Preferences: **
- Proven experiences and leadership assignments demonstrating bold leadership, exemplary team attributes, effective communications with peers and executive leaders, and effective conflict management skills
- Travel expected (10-15%)
- 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
- Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives
- 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, 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
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$169,500 - $248,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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