Katalyst CRO · 2 months ago
Regulatory Affairs Manager � CMC
San Francisco, CA
Contract
Onsite
Mid, Senior Level
5+ years expKatalyst CRO is seeking a Regulatory Affairs Manager to support the preparation and submission of CMC sections for regulatory filings. The role involves coordinating with internal stakeholders, maintaining submission plans, and ensuring compliance with evolving regulatory requirements in the biotechnology industry.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Support preparation, review, and submission of CMC sections for U.S and global regulatory filings (INDs/CTAs, amendments, and BLAs/MAAs)
Coordinate with internal stakeholders to gather technical information and ensure accuracy and consistency across CMC documentation
Assist in developing and maintaining submission plans for assigned programs
Review change controls and manufacturing documentation
Track and interpret evolving regulatory requirements and guidance relevant to cell and gene therapy manufacturing, testing, and control
Support interactions with domestic and global health authorities, including preparation of meeting materials, responses to information requests, and briefing documents
Maintain regulatory databases, document systems, and submission archives in compliance with internal procedures
Qualification
Required
BA/BS in a scientific field and 5 years experience or MBA/MS with minimum 2 years' experience
3 years of experience supporting Regulatory Affairs and/or CMC functions in the Biotechnology industry
Experience with lentiviral vectors, cell and gene therapy process development and/or analytical method development
Understanding of FDA regulations, and ICH GCP guidelines
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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