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Lilly Advisor / Director, Global Regulatory Affairs, North America – Oncology in St. Paul, Minnesota

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 39,000 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.

At Eli Lilly, we create medicines that give people new hope – to get better, feel better, live better. It’s our purpose to create medicines that make life better for people around the world. Lilly is looking for regulatory leaders to join us in developing and bringing life-changing new medicines to patients who need them all over the world. To learn more about Lilly and our strong foundation in oncology, please visit us at lilly.com and lilly.com/newsroom .

The Advisor / Director of Global Regulatory Affairs, North America – Oncology serves as the regulatory regional lead for assigned oncology product(s). As the regulatory lead you will be responsible for driving the regulatory strategy for development, registration, and lifecycle management in the US and Canada. He/she may also serve as the global regulatory coordinator. You will to take calculated risks and leverage innovative regulatory strategies that can accelerate the development of assigned product(s). You will identify and delegate tasks to others on the regulatory team, and this role may involve line management of more junior regulatory scientists.

Key Responsibilities:

  • Drivessolutions.Accountablefor the regulatorysuccess of highpriority or complex oncology molecules in development

  • Provides leadership by defining and executing innovative regulatory and labeling strategies for assigned product(s) across the product lifecycle

  • Works independently in a role that demonstrates organizational influence within and across functions

  • Acts as direct liaison with FDA and Health Canada

  • Executes high quality communications with regulators and internal customers to articulate and ensure understanding of the regulatory strategy and complex issues

  • Activelyseekstodeepenregulatoryknowledgethroughconstant learning

  • Readily shares information and regulatory knowledge with others

  • Engages in, influences, and shapes external environment initiatives related to portfolio assets

Minimum Qualification Requirements:

  • Bachelors degree in a scientific area with at least 5 years of industry-related experience in regulatory affairs and/or drug development

Additional Skills and Preferences:

  • Advanced scientific degree (i.e. PhD, MD, PharmD) preferred

  • Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory initiatives desirable

  • Demonstrated deep knowledge of the drug development process; oncology experience preferred

  • Demonstrated ability to assess and manage risk in a highly regulated environment

  • Demonstrated strong written, spoken and presentation communication

  • Demonstrated negotiation and influence skills

  • Demonstrated attention to detail

  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Additional Information:

Location-Indianapolis IN OR remote

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

#WeAreLilly

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