cGxPServe
Responsibilities
Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports. Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols. Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities. Strategy Implementation: Execute CMC regulatory strategies as defined by regulatory leadership to support clinical trial initiation and advancement. Cross-functional Collaboration: Partner with Technical Operations, Quality, Manufacturing, and external vendors to gather, verify, and compile CMC information. Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations. Other duties as assigned. Requirements
Bachelor's degree with a minimum of 5+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related experience. Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings. Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH. Experience with biologics, drug-device combination products (e.g., pre-filled syringes, auto-injectors), or diagnostics (companion diagnostics) preferred. Excellent attention to detail, technical writing, organizational, and communication skills. Ability to manage multiple deliverables and timelines in a fast-paced environment. Proficiency with regulatory document management systems. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Research Services
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Author and compile CMC sections of regulatory applications, including INDs, IMPDs, CTAs, amendments, and annual reports. Documentation: Draft and maintain high-quality CMC regulatory documents such as Module 2 and 3 summaries, stability reports, and comparability protocols. Communication: Support regulatory interactions by preparing responses to CMC-related questions from FDA, EMA, PMDA, and other global health authorities. Strategy Implementation: Execute CMC regulatory strategies as defined by regulatory leadership to support clinical trial initiation and advancement. Cross-functional Collaboration: Partner with Technical Operations, Quality, Manufacturing, and external vendors to gather, verify, and compile CMC information. Process Development: Contribute to the development of templates, processes, and workflows to support efficient and compliant CMC regulatory operations. Other duties as assigned. Requirements
Bachelor's degree with a minimum of 5+ years of experience in CMC regulatory affairs, including experience with clinical biologics programs or equivalent related experience. Hands-on experience authoring and compiling CMC sections of INDs, IMPDs, CTAs, amendments, and related filings. Strong knowledge of global CMC clinical regulatory requirements and guidelines, including FDA, EMA, and ICH. Experience with biologics, drug-device combination products (e.g., pre-filled syringes, auto-injectors), or diagnostics (companion diagnostics) preferred. Excellent attention to detail, technical writing, organizational, and communication skills. Ability to manage multiple deliverables and timelines in a fast-paced environment. Proficiency with regulatory document management systems. Seniority level
Mid-Senior level Employment type
Full-time Job function
Legal Industries
Research Services
#J-18808-Ljbffr