The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to developand 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 USsubmissions 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 andmaintain 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 brandgoals.
- 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 externa
