Associate Principal Scientist (Associate Director) - Regulatory Affairs - CMC, Biologics

Associate Principal Scientist, Regulatory CMC - Biologics (R4) Responsibilities Implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in accordance with domestic and international regulations and guidance. Prepare and submit CMC sections for commercial or new biologics products. Assist with development and implementation of internal regulatory strategies; provide mentoring and coaching to Sr. Scientist / Scientist. Participate in the authorization process to prioritize submissions. Complete detailed global regulatory assessments per established guidelines/policies and timelines. Develop and execute global regulatory strategies for submission/approval of INDs, BLAs, and/or post-approval change documentation. Plan, track, and communicate submission/approval status to support continued product supply. Lead authoring of clear, concise, effective IND/CTAs, BLAs, and/or global post-approval submissions per timelines. Collaborate with partner groups to ensure compliance, scientific excellence, accuracy, and completeness. Resolve project issues via cross-team collaboration and escalation to CMC leadership as appropriate. Participate in early/late development programs and departmental/cross-functional efforts to improve CMC content/processes. Education B.S. in a science, engineering, or related field (advanced degree preferred). Related fields include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Required Experience and Skills At least 10 years subject matter expertise in biologics CMC development or manufacturing, including prior biologics IND, BLA, and/or post-approval filing experience. Biologics regulatory CMC experience in both pre-approval and registration, including authoring agency interactions, responses to questions, and IND/IMPD and BLA sections. Strong understanding of related areas (e.g., manufacturing, process development, analytical, quality assurance) and ability to solve new/diverse problems creatively. Experience critically reviewing scientific information and evaluating whether arguments are clear and supported by data. Superior oral and written communication skills in multicultural settings; ability to communicate complex issues succinctly and logically. Flexibility to respond to changing priorities and unexpected events. Demonstrated leadership, project management, communication, interpersonal, and negotiating skills. Ability to generate innovative solutions to complex regulatory problems and work effectively with key stakeholders. Preferred Experience and Skills Experience with ADCs through commercialization. Preferred fields of study: Microbiology, Virology, Molecular Biology, Engineering, or Biochemistry. Required Skills (as listed) Accountability, Adaptability, Cross-Cultural Awareness, Detail-Oriented; eCTD, Documentation; International Regulatory Compliance; Regulatory CMC/Compliance; Biologics License Application (BLA); Manufacturing; Regulatory Affairs Management; Employee Training Programs; plus related biochemistry/immunology/pharmaceutical process development skills. #J-18808-Ljbffr Scorpion Therapeutics