Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity

Eli Lilly • Indianapolis, IN

127d • $162,000 - $237,600

About The Position

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 builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists) and forms and maintains a highly effective global regulatory team. The GRL creates and maintains the Regulatory Strategy Document (RSD) and ensures local plans, built 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.

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 with 10+ years of industry-related experience in regulatory affairs and/or drug development experience.
• Proven experiences and leadership assignments demonstrating bold leadership, effective communications with peers and executive leaders, and effective conflict management skills.
• 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 desirable.
• Demonstrated deep knowledge of the integrated drug development process and regulatory/business strategies.
• Demonstrated ability to find solutions and alternatives through teamwork embracing inclusion resulting in positive business outcomes.
• Strong written, spoken and presentation communication.
• Demonstrated ability to assess and manage risk in a highly regulated environment.

Nice To Haves

• Anticipated travel of 10-15%.

Responsibilities

• Develop, Update and Implement the Global Regulatory Strategy.
• Initiate and Update Regulatory Strategy Document (RSD).
• Acquire input from the global regulatory team members to develop a global regulatory strategy which supports product development, registration, and lifecycle maintenance globally.
• Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecycle.
• 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 using team expertise.
• Integrate information from the external environment, product specific regulator advice, and other public information to develop robust, innovative regulatory strategies and solutions.
• Provide input for and attend key regulatory agency meetings, as needed.
• Enable discussion of the RSD and regulatory issues/challenges at the Regulatory Strategy Forum.
• Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment.
• Ensure strategic messaging and content of global regulatory submission documents.
• Provide regulatory direction in the development of the core data sheet and claims mapping.
• Provide timely and effective communication updates to the GBD teams and BU management.
• Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications.
• Ensure 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.
• Support development teams in strategic planning, trial design and registration strategies for all in-scope countries.
• Engage in, influence, and shape external environment initiatives related to portfolio assets.
• 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.
• Lead/Influence/Partner with internal and external stakeholders.

Benefits

• 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree