Global Regulatory CMC Manager

Katalyst CRO, Village of Tarrytown, NY, United States

Global Regulatory CMC Manager – Katalyst CRO

Participate in the development of the CMC regulatory strategy for small molecules, including health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings.
Prepare and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities through collaboration with relevant line functions.
Perform global regulatory evaluation of CMC change controls under supervision.
Manage CMC activities related to developmental or commercial compounds, with supervision.
Represent Regulatory CMC on cross‑functional development/commercial teams and on Regulatory Affairs teams.
Participate in global regulatory interactions with health authorities, with supervision.
Facilitate document review meetings and discussions.
Develop and maintain knowledge of the regulatory environment, regulations, and procedures.

BS/BA degree in a scientific discipline (master’s or higher preferred).
5+ years in the pharmaceutical industry, with at least 2+ years of CMC regulatory experience.
Experience with CMC regulatory documents (IND/CTAs, NDAs, MAAs, responses, variations, and briefing documents).
Knowledge of FDA, EMA, and/or ICH guidelines and CMC regulations.
Experience in drug development processes and post‑approval requirements.
Experience in developing CMC regulatory strategy.
Experience in project management.
Solution‑oriented approach to problem solving.
Ability to plan and prioritize work of group members and guide/develop others.
Ability to work on complex projects and within cross‑functional teams with supervision.
Excellent written and oral communication skills.

Mid‑Senior Level

Contract

Legal

Pharmaceutical Manufacturing

#J-18808-Ljbffr