Sr. Director - Global Regulatory Lead - Neuroscience / Immunology

Senior Director Global Regulatory Affairs, Global Regulatory Lead

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.

The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies for products 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 function, 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 and Canada 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 Lifecycle (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

Represent Regulatory on the GBD / Global Program Team

For Preclinical and Early Clinical Development Programs : Lead and develop the US and Canada strategy for submission and amendments for IND, IDE, CTA

Engage in, influence, and shape external environment initiatives related to portfolio assets

Review corporate communications press releases

Lead / Influence / Partner

Minimum Qualification Requirements :

Other Information / Additional Preferences :