Senior Director, Regulatory Affairs DICE

Eli Lilly and Company

Be accountable for leading the development of strategic plans for pipeline assets and implementation.
Provides leadership on project teams in all areas of regulatory affairs
Develop regulatory strategies across multiple regulatory activities (CMC, nonclinical, and clinical) to ensure timelines and achievements are met to support the business needs of the company
Plan, implement, and lead successful regulatory agency meetings and interactions per regulatory strategy
Define content for and direct the organization and preparation of high quality and effective regulatory submissions, including future applications (e.g., CTA and IND)
Review and approve clinical study protocols, informed consent forms, statistical analysis plans, clinical study reports, investigator brochures, responses to regulatory agencies and all regulatory submissions
Serve as regulatory liaison with global health authorities, business partners, and CROs
Play a key role as a member of the Development Leadership Team
Understands and maintain knowledge and monitor changes in pertinent laws, regulations and guidance’s and takes a leadership role in assessing and communicating the impact of these requirements to the business

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