Regulatory Affairs Manager (Menlo Park) 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
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Job Tags

Full time, Contract work,

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