CMC Regulatory Affairs Manager
Clinical Resource Network (CRN) - florham park, NJ
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Our client is looking to fill the role of CMC Regulatory Affairs. This position will be hybrid and based out of the Florham Park office.Salary: $140-150kResponsibilities:Full lifecycle management of approved NDAsPreparing and submitting NDA annual reports, post-approval CMC supplementsSubmission activities in eCTD formatProvide regulatory assessments of CMC change controlsDefine, prepare, and submit relevant documents required to support approvals of supplemental NDAsRegulatory support for state and FDA inspections.Regulatory SOPs and reviewing and implementing policies and procedures.Required Qualifications: Bachelor's degree in scienceMinimum 5 years of Regulatory Affairs experience in the industrySAP and Trackwise experienceKnowledge of relevant good manufacturing regulations in 21 CFR 211 & 111 and relevant FDA guidance for post approval changes and SUPACFluent in English and Spanish idealIf 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 CRNFounded 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.
Created: 2024-07-07