Senior Advisor/Director, Global Regulatory Affairs – CMC, Pre-approval, Small Molecules

Role Summary

Senior Advisor/Director, Global Regulatory Affairs – CMC, Pre-approval, Small Molecules. Drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides.

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.

Qualifications

• 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.

Additional Skills

• 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.

Education

Additional Requirements

• Position Location: Indianapolis, IN. This is not a remote position. Relocation assistance is provided.
• Travel: minimal within the US