Manager/Senior Manager, 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 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.

Company Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Overview:

The Manager/Senior Manager– CMC Regulatory is responsible for the preparation and delivery of high-quality CMC regulatory submissions.  This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally.

Responsibilities:

• Responsible for the generation and execution of country specific CMC regulatory strategies
• Author and review global CMC dossiers
• Coordinate and contribute to responses to regulatory agency questions
• Participate as an active member of cross-functional teams and ensure alignment of global regulatory strategies with CMC development and commercial plans
• Maintain submission information according to the Regulatory Information Management (RIM) system.
• Support CMC regulatory assessment for change controls
• Keep current with global regulatory guidelines applicable to CMC
• Perform other duties as assigned.

Basic Qualifications:

• Bachelor’s degree in chemistry or related field, or PharmD
• Experience in pharmaceutical development and/or manufacturing with a minimum of two years of CMC regulatory experience or related (e.g. CMC writer)

Additional Skills/Preferences:

• Excellent technical writing skills
• Strong communication skills with ability to work within global multi-disciplinary teams
• Ability to plan, prioritize and handle multiple tasks concurrently
• Ability to independently complete assigned workload with minimum supervision
• Ability to adapt to change and work in a fast-paced environment
• Organized and detailed orientated
• Strong MS Office skills
• Must be willing and able to travel within the USA and worldwide 10% of time

Additional Information:

• Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response. 

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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