At Lilly, we unite caring with discovery to make life better for people around the world. We are seeking a Director - Global Regulatory Affairs (GRA) for the EMEA region to establish the local regulatory strategy and plan for assigned products. You will be accountable for ensuring the local plan aligns with the global strategy, delivering high-quality submissions and approvals, and incorporating regional business needs.
What You'll Do
- Provide region/country input and review of global strategic plans and global/regional submission documents.
- Contribute to key governance committees on regional regulatory strategy decisions.
- Ensure approval and delivery of content for local regulatory submissions, engaging cross-functional partners.
- Own the relationship and lead meetings and interactions with regulators in the assigned region.
- Lead development of local/regional labeling strategy and network for alignment across affiliate teams.
- Ensure compliance with all applicable regulations and internal quality systems.
- Provide up-to-date expertise on regional registration procedures.
- Interpret and anticipate the impact of new guidelines and initiate change in response to a changing environment.
- Own all regulatory activities in support of assigned marketed products in the region/country.
- Be involved in medical device/in-vitro diagnostics regulatory activities and potentially serve as, or perform the responsibilities of, the medical device UK Responsible Person or EU Authorized Representative.
- Ensure the registration needs for local patients in clinical trials are met for countries in the region.
- Partner with Global Regulatory Leads to help solve development and regulatory issues impacting local registrations and to ensure robust submission sequencing strategies.
- Liaise with affiliates to anticipate region/country-specific issues and the impact of labeling on promotion, pricing, and reimbursement.
- Participate in regional meetings to ensure regulatory strategy and issues are considered.
- Participate in forums that share regulatory information across GRA components and other Lilly teams.
- Propose continuous improvement projects to simplify processes and increase productivity.
- Lead or represent the regulatory function on cross-functional non-product related projects.
- Serve as a mentor for GRA personnel.
- Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in all interactions.
- Model innovation, leadership behaviors, and regulatory excellence attributes.
- Constructively challenge teams to reach the best solutions to issues.
- Create and lead in an environment of equity and inclusion that encourages open discussion to achieve robust business outcomes.
What We're Looking For
- An advanced scientific degree (i.e., PhD, MD, PharmD) or a bachelor’s degree with significant relevant industry-related experience in regulatory affairs and/or drug development.
- Industry-related experience in regulatory affairs and/or drug development.
- Knowledge of local/regional regulatory procedures and practices.
- Demonstrated knowledge of the integrated drug development process and regulatory/business strategies.
- Demonstrated ability to find solutions through teamwork embracing diversity, equity, and inclusion.
- Demonstrated ability to assess and manage risk in a highly regulated environment.
- Strong written, spoken, and presentation communication skills.
- Demonstrated negotiation and influence skills.
- Demonstrated attention to detail.
Nice to Have
- Awareness of evolving regulatory reform initiatives.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
