Sr Manager, Regulatory Affairs CMC

Senior Manager, CMC Regulatory Affairs for Biologics Responsibilities Serve as CMC regulatory lead for a single or multiple products. Prepare and submit complex regulatory documents requiring cross‑department interaction for investigational and commercial products (e.g., safety reports, amendments, supplements, license renewals for clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories). Contribute to regulatory strategy and solutions for CMC challenges for clinical or commercial projects. Interpret and implement ICH and other global guidelines to achieve an approved/harmonized regulatory control strategy. Partner across CMC Regulatory Affairs, PDM, and other functional groups. Qualifications Undergraduate or advanced degree in life sciences (or related field) with significant CMC/manufacturing/research/development/regulatory experience in biopharma; minimum experience: 8 years with BA/BS, 6 years with MA/MS/MBA, or 2 years with PhD/PharmD. Significant experience managing life‑sciences regulatory filings, including independent completion of routine submissions. In‑depth knowledge of global CMC regulatory landscape. Ability to develop/implement regulatory strategy and lead small teams. Excellent collaboration/organizational skills; strong verbal/written communication and presentation skills. Benefits $157,590.00–$203,940.00 salary range; may be eligible for bonus, stock‑based incentives, paid time off, and company‑sponsored medical/dental/vision/life insurance. #J-18808-Ljbffr