Katalyst CRO · 3 months ago
Regulatory Affairs CMC Associate
San Diego, CA
Contract
Onsite
Mid Level
4+ years expKatalyst CRO is seeking a Regulatory Affairs CMC Associate to provide support for biologic and small molecule drugs in the treatment of oncology, HIV, and liver disease. The role involves preparing and submitting regulatory documents, maintaining knowledge of regulatory requirements, and working cross-functionally within a matrixed organization.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology, HIV and liver disease
The Associate, working with the project team and regional regulatory leads in the US, EU and other countries, will support documentation for submission to regulatory authorities
May serve as regional lead on cross-functional/ cross-regional Regulatory Submission Teams
Responsible for preparing and submitting regulatory documents which require interaction with departments in and outside of Regulatory Affairs CMC for investigational and commercial biologics and small molecule products, in line with ICH requirements, regional requirements and scientific and company policies and procedures
Examples include original INDs, NDAs, BLAs, amendments, supplements, annual reports and license renewals
Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions
Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory Department
Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is updated and maintained in accordance with the product license as applicable
Maintains knowledge of regulatory requirements and communicates changes in regulatory information to line manager and regulatory project teams in a timely manner
Work cooperatively with regional regulatory sites to support the accurate and timely communication of critical information
Provide support for cGMP activities as they relate to Regulatory Affairs CMC
Work is performed cross-functionally within a matrixed organization under supervision of senior Regulatory Affairs CMC professionals and line manager
Qualification
Required
Excellent organizational skills and ability to work on multiple projects with tight timelines is required
Excellent verbal and written communication skills and interpersonal skills are expected
Must work well under demanding deadlines and have excellent attention to detail
Must have a reasonable understanding of regulatory requirements, including ICH requirements and US regional requirements
Preferred
BS/BA Degree in Scientific field preferred and 4 years of relevant Pharmaceutical/Biotech industry experience, for example in Regulatory Affairs CMC
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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