Sr. Director - Global Regulatory Lead – Early Clinical DevelopmentApply locations Ireland, Cork time type Full time posted on Posted 30+ Days Ago job requisition id R-69792
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 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.
Responsibilities:
The Sr. Director, Global Regulatory Lead – Early Clinical Development serves as the regulatory regional lead for assigned molecules in development. As the regulatory lead, the Sr.
Director will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies.
The Sr.
Director will also partner with other global regulatory scientists to develop and execute global regulatory strategy outside the US and Canada.
The Sr.
Director will be expected to take reasoned risks and leverage innovative regulatory strategies that can accelerate the development of assigned molecules.
Key responsibilities include:
Provides leadership by developing and executing innovative regulatory strategiesWorks independently in a role that demonstrates organizational influence within and across functions.
For example, influences cross-functional teams on clinical development strategy and trial designActs as direct liaison with FDA and Health CanadaExecutes high quality communications with regulators and internal customers to articulate and ensure understanding of the regulatory strategy and complex issuesActively seeks to deepen regulatory knowledge through constant learningReadily shares information and regulatory knowledge with othersEngages in, influences, and shapes external environment initiatives related to portfolio assets
Basic Requirements:
Bachelor's degree in scientific area and at least 10 years of industry-related experience in regulatory affairs and/or drug developmentORAdvanced scientific degree (e.g., PhD, PharmD) with at least 8 years of industry-related experience in regulatory affairs and/or drug developmentAdditional Skills/Preferences: Knowledge of FDA and Health Canada procedures and practices and awareness of evolving regulatory initiatives desirableDemonstrated deep knowledge of the drug development processDemonstrated ability to assess and manage risk in a highly regulated environmentDemonstrated strong written, spoken and presentation communication skillsDemonstrated ability to negotiate and influenceDemonstrated attention to detailDemonstrated effective teamwork skills; able to adapt to diverse interpersonal styles
Additional Information:
Ability to travel to US required (10-25%)
Position location:
Cork, IrelandEli 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 (
) for further assistance.
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.
About UsAt 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.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe
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