Regulatory Affairs Manager Job at Katalyst CRO, Menlo Park, CA

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  • Katalyst CRO
  • Menlo Park, CA

Job Description

Join to apply for the Regulatory Affairs Manager role at Katalyst CRO . Responsibilities include: Managing the company's regulatory interface with domestic and international health authorities. Developing and deploying regulatory programs to ensure product approval. Preparing and submitting regulatory documents for new products and changes to existing filings. Managing clinical study submissions. Ensuring compliance with governmental regulations affecting company processes. Collaborating with teams across the organization (Clinical Operations, R&D, Quality, etc.). Guiding localization and labeling requirements. Managing regulatory reporting. Requirements: Bachelor's or advanced degree in a scientific discipline (M.S., Pharm.D., M.D., Ph.D.) preferred. 5+ years of experience in Regulatory Affairs within biotech or pharma industries. Strong analytical, problem-solving, and communication skills. Additional Details: Seniority level: Mid-Senior level Employment type: Contract Job function: Legal Industry: Pharmaceutical Manufacturing #J-18808-Ljbffr Katalyst CRO

Job Tags

Contract work,

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