CMC Regulatory Affairs Specialist
4 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, including contingency plans for post-approval changes.
- Manage the preparation of INDs, BLAs, CTAs, amendments, supplements, and reports, ensuring compliance with regulatory requirements.
- Participate in Health Authority CMC meeting preparations, rehearsals, and meetings, providing expert guidance on regulatory and scientific/technical matters.
- Collaborate with cross-functional teams to ensure alignment on CMC regulatory strategies and submissions.
Required Qualifications:
- Strong understanding of drug development processes, pharmaceutical technology, and GMP regulations.
- Expertise in CMC regulatory requirements for biologics and small molecules, including development through post-approval.
- Global regulatory knowledge and experience with US, Europe, and Canada submissions.
- Experience with CMC quality submission preparation for investigational and marketed products (IND, NDA, DMF).
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field, with a Master's or Ph.D. in a scientific discipline preferred.
- RAC certification a plus.
- 7+ years of CMC regulatory experience in the pharmaceutical industry.
Clinical Resource Network (CRN) offers a comprehensive benefits program, including medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits. We pride ourselves on forming long-term relationships with our clients and candidates, providing clinical research and talent solutions for pharmaceutical, biotech, and medical device companies.
About CRN
Founded in 2002, Clinical Resource Network (CRN) provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. We focus on forming long-term relationships, offering contract staffing, project staffing, consultative services, and full-time placements. For more information, visit our website and connect with us on Facebook and LinkedIn.
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