Regulatory Affairs Manager (Menlo Park)

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