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Regulatory Affairs Manager

2 months ago

Princeton, New Jersey, United States Clinical Resource Network (CRN) Full time
Job Summary

Clinical Resource Network (CRN) is seeking a highly skilled CMC Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance on CMC regulatory matters for investigational, new, and marketing products.

Key Responsibilities
  • CMC Regulatory Strategy: Develop and implement CMC regulatory strategies for biologics and small molecule products, including investigational and marketing products.
  • Regulatory Submissions: Prepare and manage INDs, BLAs, CTAs, amendments, supplements, and reports for regulatory submissions.
  • Health Authority Meetings: Participate in Health Authority CMC meeting preparations, rehearsals, and meetings to ensure successful outcomes.
  • Regulatory Knowledge: Stay up-to-date with global regulatory requirements and guidelines for CMC and GMP-related submissions.
Requirements
  • Education: Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharm.D., with a Master's or Ph.D. in a scientific discipline.
  • Experience: 7+ years of CMC regulatory experience in the pharmaceutical industry, with a strong understanding of drug development processes, pharmaceutical technology, and GMP.
  • Skills: Strong analytical and problem-solving skills, with excellent communication and project management skills.
  • Certifications: RAC certification is a plus.
About Clinical Resource Network (CRN)

Clinical Resource Network (CRN) is a leading provider of clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. We pride ourselves on forming long-term relationships with our clients and providing exceptional service.