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Global Regulatory Affairs Director
2 months ago
We are seeking a highly skilled Global Regulatory Affairs Director to join our team at Eli Lilly and Company. This role will be responsible for establishing local regulatory strategies and plans for assigned products in the region/country, ensuring local regulations and region/country business needs are included.
Key Responsibilities- Establish Local Regulatory Strategies: Develop and implement local regulatory strategies and plans for assigned products in the region/country, ensuring alignment with global regulatory strategies.
- Provide Regulatory Expertise: Provide regional regulatory expertise in delivering high-quality and efficient regulatory submissions, approvals, and local labeling for assigned products.
- Manage Regulatory Activities: Own all regulatory activities in support of assigned marketed products in the region/country, ensuring compliance with all applicable regulations and internal quality systems.
- Collaborate with Global Teams: Partner with Global Regulatory Leads to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for countries in assigned regions.
- Lead Cross-Functional Projects: Lead or represent the regulatory function on cross-functional non-product related projects, modeling innovation, leadership behaviors, and regulatory excellence attributes.
- Education: Bachelor's degree in scientific or health sciences discipline.
- Experience: Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 5 years.
- Knowledge: Knowledge of local/regional regulatory procedures and practices, awareness of evolving regulatory reform initiatives, and demonstrated knowledge of the drug development process.
- Skills: Demonstrated ability to find solutions and alternatives through teamwork, embracing diversity, equity, and inclusion, resulting in positive business outcomes, and demonstrated ability to assess and manage risk in a highly regulated environment.
Eli Lilly and Company is 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.
