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
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
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 https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
