Katalyst CRO
Global Regulatory CMC Manager – Katalyst CRO
Irvine, CA | $96,100 – $145,310
Responsibilities
Develop the CMC regulatory strategy for small molecules, including briefing packages, IND/CTA, NDA, and MAA filings.
Prepare and review CMC submission documents, registration dossiers, and health authority responses with minimal supervision.
Evaluate global regulatory change controls for CMC with supervision.
Manage CMC activities related to developmental or commercial compounds with supervision.
Represent Regulatory CMC on cross‑functional development/commercial teams and Regulatory Affairs teams.
Participate in global regulatory interactions with health authorities with supervision.
Facilitate document review meetings and discussions.
Maintain knowledge of the regulatory environment, regulations, and procedures.
Qualifications
BS/BA in a Scientific Discipline (master's or higher preferred).
5+ years in the pharmaceutical industry, with 2+ years 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 developing CMC regulatory strategy.
Experience in project management.
Solution‑oriented approach to problem solving.
Ability to plan/prioritize work of group members and guide/develop others.
Ability to work on complex projects and within cross‑functional teams with supervision.
Excellent communication skills, both written and oral.
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Responsibilities
Develop the CMC regulatory strategy for small molecules, including briefing packages, IND/CTA, NDA, and MAA filings.
Prepare and review CMC submission documents, registration dossiers, and health authority responses with minimal supervision.
Evaluate global regulatory change controls for CMC with supervision.
Manage CMC activities related to developmental or commercial compounds with supervision.
Represent Regulatory CMC on cross‑functional development/commercial teams and Regulatory Affairs teams.
Participate in global regulatory interactions with health authorities with supervision.
Facilitate document review meetings and discussions.
Maintain knowledge of the regulatory environment, regulations, and procedures.
Qualifications
BS/BA in a Scientific Discipline (master's or higher preferred).
5+ years in the pharmaceutical industry, with 2+ years 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 developing CMC regulatory strategy.
Experience in project management.
Solution‑oriented approach to problem solving.
Ability to plan/prioritize work of group members and guide/develop others.
Ability to work on complex projects and within cross‑functional teams with supervision.
Excellent communication skills, both written and oral.
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