Katalyst CRO ยท 1 month ago
Project Manager, Regulatory CMC
Paramus, NJ
Contract
Onsite
Senior Level
5+ years expKatalyst Healthcares & Life Sciences is seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format
Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals
Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions
Ensure compliance with FDA, EMA, and ICH guidelines and internal processes
Collaborate with cross-functional teams to gather accurate technical information
Identify and communicate potential regulatory risks; propose mitigation strategies
Support process improvement initiatives for CMC submission workflows
Qualification
Required
Minimum 5 years in pharmaceutical regulatory writing or CMC project management
Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities
Familiarity with global regulatory frameworks and eCTD submissions
Excellent technical writing, communication, and organizational skills
Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint)
Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format
Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals
Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions
Ensure compliance with FDA, EMA, and ICH guidelines and internal processes
Collaborate with cross-functional teams to gather accurate technical information
Identify and communicate potential regulatory risks; propose mitigation strategies
Support process improvement initiatives for CMC submission workflows
Preferred
Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings
Ability to interpret and apply regulatory guidelines effectively
Strong project management and stakeholder communication skills
Veeva Vault, Smartsheet are plus
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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