CMC Regulatory Affairs Manager
2 weeks ago
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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