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CMC Regulatory Compliance Associate

2 months ago

San Mateo, California, United States The Fountain Group Full time

Position Overview:
We are seeking a qualified candidate with expertise in Pharmaceutical Regulatory CMC to join our team. While preference is given to local candidates, we are open to considering individuals located within the Pacific time zone who possess the necessary experience.

Key Responsibilities:

  • Prepare and manage moderately complex regulatory submissions, collaborating with various departments outside of Regulatory Affairs CMC for investigational products across multiple regions, ensuring compliance with ICH guidelines, regional regulations, and internal policies.
  • Oversee routine approvals and modifications of clinical and commercial labeling, conduct protocol assessments, and ensure that product packaging and related information are consistently updated in accordance with licensing requirements.
  • Continuously develop and enhance knowledge of regulatory standards both independently and in conjunction with the line manager.
  • Evaluate change controls for their regulatory implications in different regions and document assessments using various internal systems.
  • Contribute to the enhancement of local processes that positively influence the functioning of the RA CMC team and other departments.
  • Independently plan, organize, and execute activities in alignment with project objectives and timelines.
  • Demonstrate leadership capabilities by guiding a small team in the preparation of regional submissions.
Education & Experience Requirements:
Required:
  • Bachelor's Degree with at least 6 years of relevant training or industry experience in a GMP setting, or a Master's Degree with a minimum of 4 years of relevant training or industry experience in a GMP environment.
Preferred:
  • Degree in a relevant scientific discipline.
  • Experience with Regulatory CMC submissions.
  • Regulatory Affairs Certification (RAC) is a plus.
Compensation: $50 - $70 per hour
Contract Duration: 12+ months