Advisor - Global Regulatory Affairs-CMC Biologics

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:

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 Description:

We are seeking Advisor/Senior Advisor for Global Regulatory Affairs CMC-Biotechnology to be a part of the Lilly global regulatory group to support global submissions and registrations.  As the project leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support for clinical trial applications, market registrations and post-approval submissions. The Research Scientist in Global Regulatory Affairs – CMC Biotechnology will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the bioproduct portfolio. The regulatory scientist will be expected to develop and implement innovative regulatory strategies to advance the development of assigned product(s).

Responsibilities:

• Deep technical knowledge of CMC drug development science(s)

• Knowledge of bioproduct CMC global regulatory requirements and guidelines for conducting clinical trials and obtaining global product marketing registrations

• Development of regulatory strategy to ensure alignment with current and evolving global regulatory expectations

• Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning

• Leads preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions

• Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content

• Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members

Basic Requirements:

• B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar)

• Five years of experience supporting clinical phases of development and/or commercialization, experience should include authoring CMC submission content, and involvement in clinical trial and commercial processes including response to questions

Additional preferences and Skills:

• Experience in biotechnology drug substance and/or drug product development, commercialization, or manufacturing

• Advanced degree preferred

• Demonstrated deep knowledge of the biologic drug development process. Knowledge of new modalities (ie., antibody conjugates, cell gene therapy products) preferred but not required.

• Experience planning for and participating in Health Authority meetings

• Knowledge of major market procedures, regulations and practices. Awareness of evolving regulatory initiatives desirable.

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

• Demonstrated strong written, verbal and presentation communication skills.

• Demonstrated leadership behaviors and negotiation and influence skills.

• Demonstrated attention to detail

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

Additional Information:

• Position Location: Indianapolis but remote will be considered

• Travel:  minimal within the US

For internal employees, if you are currently in a technical path role, but outside of the posting band, you may apply. You will be hired at your current level. For example: Current P4 (tech ladder), Posting R1-2 tech ladder, hire will occur at P4

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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