Sr. Director
Found in: Talent IE C2 - 2 weeks ago
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, Regulatory Scientist North America – 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
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.
#WeAreLilly
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