Senior Advisor, Global Regulatory Affairs, CMC, Biotechnology

Industry:

Company: Eli Lilly and Company

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.

At Eli Lilly, we create medicines that give people new hope – to get better, feel better, live better. It’s our purpose to create medicines that make life better for people around the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control (CMC) scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world.

We are seeking Regulatory Scientist GRACMC-Biotechnology to be a part of the Lilly post-approval 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 market registrations and post-approval submissions. The regulatory 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 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).

Key responsibilities / expectations:

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

• Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug product manufacturing 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

Minimum Requirements

• B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar) with a minimum of 15 years of regulatory CMC experience or equivalent (such as time spent in supporting CMC functions with regulatory submission experience)

OR

• Advanced degree (PhD, MS) in a science, engineering or related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar) with a minimum of 4 years of regulatory CMC experience

Preferred Experiences and Skills

• Experience in biotechnology drug substance and/or drug product development, commercialization or manufacturing
• Demonstrated deep knowledge of the biologic drug development process.
• Bioproduct Regulatory CMC 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
• Knowledge of major market procedures, regulations and practices. Awareness of evolving regulatory initiatives desirable.
• Experience planning for and participating in Health Authority meetings
• 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: Relocation to Indianapolis preferred; remote option might be considered
• Travel: minimal within the US

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.

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.

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