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.

Lilly offers a premium workspace across our campus in Little Island,  complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.  Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

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 strategies

Works independently in a role that demonstrates organizational influence within and across functions. For example, influences cross-functional teams on clinical development strategy and trial design

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

Actively seeks to deepen regulatory knowledge through constant learning

Readily shares information and regulatory knowledge with others

Engages 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 development

OR

Advanced scientific degree (e.g., PhD, PharmD) with at least 8 years of industry-related experience in regulatory affairs and/or drug development

Additional Skills/Preferences:

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

Demonstrated deep knowledge of the drug development process

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

Demonstrated strong written, spoken and presentation communication skills

Demonstrated ability to negotiate and influence

Demonstrated attention to detail

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

Additional Information:

Ability to travel to US required (10-25%)

Position location: Cork, Ireland

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 ( Lilly_Recruiting_Compliance@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 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.

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