CMC Regulatory Affairs Manager

2 weeks ago


Princeton, New Jersey, United States Clinical Resource Network (CRN) Full time
CMC Regulatory Affairs Manager Job Description

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 team, you will be responsible for providing strategic guidance on CMC regulatory matters for investigational, new, and marketing products.

Key Responsibilities:

  • Develop and implement CMC regulatory strategies for biologics and small molecule products.
  • Manage the preparation of INDs, BLAs, CTAs, amendments, supplements, and reports.
  • Participate in Health Authority CMC meeting preparations, rehearsals, and/or meetings.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Stay up-to-date with regulatory guidelines and developments in the CMC space.

Requirements:

  • Strong understanding of drug development processes, pharmaceutical technology, and GMP.
  • CMC regulatory requirement knowledge specifically for biologics and small molecules.
  • Experience with global regulatory submissions and knowledge of guidelines.
  • Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field.
  • RAC certification a plus.
  • 7+ years of CMC regulatory experience in pharma.

About Clinical Resource Network (CRN)

Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. We pride ourselves on forming long-term relationships and offering comprehensive benefits to our employees.

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