Senior Advisor/Director, Global Regulatory Affairs - CMC, Small Molecules
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Deep technical knowledge of synthetic molecule CMC drug development and commercialization.
- 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.
- 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 seven years of technical CMC experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
- Demonstrated deep technical knowledge of the synthetic molecule drug development and commercialization process.
- Experience authoring CMC submission content, and involvement in CTA/MAA processes including response to questions.
- Prior regulatory CMC experience supporting clinical phases of development, commercialization and/or post-approval submissions for synthetic molecules.
- Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives desirable.
- Knowledge in new molecular modalities (e.g., oligonucleotides, synthetic peptides) or new manufacturing technologies (e.g., continuous manufacturing).
- Experience planning for and/or 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.
- Position Location: Indianapolis
- Travel: minimal within the US