Global Regulatory Strategist

24 hours ago


Bracknell, Bracknell Forest, United Kingdom Eli Lilly and Company Full time
Job Summary:

Eli Lilly and Company is seeking a Global Regulatory Strategist to join our team. This role is responsible for developing and implementing global regulatory strategies for assigned products, ensuring compliance with all applicable regulations and internal quality systems.

The ideal candidate will have a Bachelor's degree in a scientific or health sciences discipline and minimum 5 years of experience in regulatory affairs and/or drug development. Knowledge of local/regional regulatory procedures and practices is essential, as well as awareness of evolving regulatory reform initiatives.

This role requires demonstrated knowledge of the drug development process, Lilly's (or external peer company) regulatory/business strategies, and the ability to assess and manage risk in a highly regulated environment. The successful candidate will be able to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes.

Key Responsibilities:

  • To develop and implement global regulatory strategies for assigned products, ensuring compliance with all applicable regulations and internal quality systems.
  • To provide global regulatory expertise in delivering high quality and efficient regulatory submissions, approvals, and labelling for assigned products.
  • May perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area.

Estimated Salary: $140,000 - $170,000 per year, depending on location and experience.

About Us: 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.



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