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Regulatory Affairs CMC Specialist

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 in the Bay Area, we are open to considering individuals located within the Pacific time zone who possess relevant experience.

Key Responsibilities:

  • Prepare and manage moderately complex regulatory submissions, collaborating with various departments outside of Regulatory Affairs CMC for investigational products in the US, Asia, and LATAM, as well as marketed products in the US, ensuring compliance with ICH guidelines, regional regulations, and internal policies.
  • Oversee routine approvals and modifications of clinical and commercial labeling, conduct protocol reviews, and ensure that drug listings and product packaging information are accurately updated in accordance with licensing requirements.
  • Continuously develop and maintain a comprehensive understanding of regulatory requirements, both independently and in collaboration with the line manager.
  • Evaluate change controls for their regulatory implications in the region and document assessments using various internal systems.
  • Contribute to enhancements in local processes that positively affect the RA CMC function and other departments.
  • Independently plan, schedule, and coordinate activities to align with project objectives and timelines.
  • Lead a small team in the preparation of regional submissions when necessary.
Education & Experience Requirements:
Mandatory:
  • 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 Qualifications:
  • Degree in a relevant scientific discipline.
  • Experience with Regulatory CMC submissions.
  • Regulatory Affairs Certification (RAC) is advantageous.
Compensation: $50 - $70 per hour
Contract Duration: 12+ months