Katalyst CRO ยท 2 weeks ago
Global Regulatory CMC Manager
Tarrytown, NY
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a company focused on regulatory affairs in the pharmaceutical industry, and they are seeking a Global Regulatory CMC Manager. The role involves developing CMC regulatory strategies, preparing submission documents, and managing CMC activities related to both developmental and commercial compounds.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Participate in the development of the CMC regulatory strategy for small molecules. These submissions include 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 collaborations with relevant line functions and with minimal supervision
Responsible for the global regulatory evaluation of CMC change controls with supervision
Responsible for the management of 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
Develop and maintain knowledge of regulatory environment, regulations, and procedures
Qualification
Required
BS/BA degree in Scientific Discipline (master's or higher preferred)
5+ years in the pharmaceutical industry, preferably 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 in developing CMC regulatory strategy
Experience in project management
Have a 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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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