Our client is looking to fill the role of CMC Regulatory Affairs Manager. This position will be fully remote.
Responsibilities:
- Provide CMC regulatory strategy for investigational, new and marketing products (biologics and small molecule focus).
- Responsible to develop CMC strategies and contingency plans for biologic/small molecule drug substances, drug products, and drug-device combination products, as well as post approval changes for marketing products.
- Responsible for determination of regulatory and scientific/technical requirements for CMC and GMP related submissions.
- Manage preparation of INDs, BLAs, CTAs, amendments, supplements, and reports.
- Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings.
Required Qualifications:
- Strong understanding of drug development process, pharmaceutical technology, drug manufacturing processes and GMP.
- CMC regulatory requirement knowledge specifically for biologics and small molecules development through post approval
- Seeking global regulatory knowledge.
- In depth knowledge of CMC quality submission preparation for investigational and marketed products (IND, NDA, DMF).
- US, Europe and Canada submissions experience and knowledge of guidelines.
- Experience in CPP application filing through eCATS, 510(j)(3) reporting through nextGen portals is a plus.
- Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. in scientific discipline
- RAC certification a plus
- 7+ years of CMC regulatory experience in pharma (previous experience with successful
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
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About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn.
Opportunity Awaits.