Senior Advisor/Director, Global Regulatory Affairs – CMC
Indianapolis, IN, United States
Lilly Senior Advisor/Director, Global Regulatory Affairs – CMC Indianapolis , Indiana Apply Now 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 Control (CMC) scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs – CMC 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 synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage innovative regulatory strategies that can accelerate the development of assigned product(s).
Key responsibilities:
Deep technical knowledge of synthetic molecule CMC drug development science(s).
Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations.
Development of regulatory strategy and update strategy based upon global regulatory changes.
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 decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.
Basic Qualifications/Requirements
B.S. degree in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
Minimum of five years of Regulatory CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. Those with greater than five years experience are encouraged to apply.
Additional Skills/Preferences
Experience authoring CMC submission content, and involvement in CTA/MAA processes including response to questions.
Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives desirable.
Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
Demonstrated deep knowledge of the synthetic molecule drug development process. Knowledge in new molecular modalities (e.g., oligonucleotides, synthetic peptides) or new manufacturing technologies (e.g., continuous manufacturing) preferred but not required.
Experience planning for and participating in Health Authority meetings.
Demonstrated ability to assess and manage risk in a highly regulated environment.
Demonstrated strong written, spoken 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
Travel: minimal within the US
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