Senior Director, CMC Regulatory

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 35,000 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.

Organization Overview:
Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly-owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing diagnostics and biomarkers that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare.

Responsibilities:
This position will provide leadership, direction, and management for the CMC regulatory operations for radiopharmaceuticals (investigational medicinal products and commercial products) globally, working in a fast-paced, multi-disciplinary environment.

• Develop the global CMC Regulatory strategies for radiopharmaceutical products to align with current and evolving globally regulatory expectation, to meet the business needs for ongoing and new clinical trials and commercial endeavors, and to enable successful approvals with minimal supply chain impact.
• Direct CMC Regulatory projects which include but not limited to new product approvals, existing product renewals, and post-approval changes for global registrations for investigational and commercial radiopharmaceutical products.  
• Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.
• Direct the authoring, review, and finalization of CMC Regulatory documentation.
• Review and approve label creation and revisions.
• Monitor and evaluate new regulations / guidance, regulatory changes / trends pertaining to CMC Regulatory and communicate with internal stakeholders under the direction of Regulatory Affairs department head.
• Develop people and stabilize the team through strong leadership to ensure continuing team support. 
• Challenge, modernize and streamline existing processes within CMC Regulatory
• Keep cross functional teams informed of status of regulatory filings as needed.
• Represent Lilly in industry regulatory associations as needed.
• Engage in forums that share regulatory information across global regulatory affairs components and other Lilly teams and business partners.
• Demonstrate an in-depth understanding of CMC Regulatory requirements across multiple regions and actively seeks to deepen regulatory knowledge through constant learning.
• Exemplify Team Lilly Behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions.
• Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Lead other tasks / projects as assigned.

Basic Qualifications:

• Bachelor’s degree in Chemistry or related field
• Minimum of 5 years of pharmaceutical industry experience

Additional Skills/Preferences:

• 10+ years of pharmaceutical industry experience
• PET drug experience preferred
• Advanced understanding of global cGMPs and CMC regulatory requirements
• Ability to manage people and drive engagement among teams
• Ability to adapt to change and be a nimble learner
• Ability to ensure accountability of oneself and others
• Ability to plan and align
• Creative thinking and ability to cultivate innovation
• Impeccable organizational skills
• Superior written and verbal communication skills
• Excellent computer skills (e.g. Word, Excel, PowerPoint, Teams)

Additional Information:

• Must be willing and able to travel within the USA and worldwide 10% of time.
• 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.

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

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