Senior Scientist, Regulatory CMC

Position Summary The Senior Scientist, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format. This role supports submission strategies for CMC modules and updates, including life cycle management; and generates submission-ready content for Quality/CMC sections of clinical trial and marketing authorization applications. Essential Functions Prepare and review Module 2 (QOS) and Module 3 documents per CTD guidance and company standards. Support development of global CMC regulatory strategies. Prepare/review pharmacy manuals, protocols, CMC reports, and other documentation. Provide input and recommendations on planned/performed CMC topics. Support design of CMC protocols. Interact with other groups to address CMC-related matters. Assist with responses to Health Authority comments/questions on CMC issues. May train others on Regulatory Affairs SOPs, processes, templates, and application sections. Perform ad-hoc/cross-functional duties and/or projects as assigned. Education & Experience (Required) Bachelor’s in life sciences/technical discipline with 6+ years; or Master’s with 4+ years; or Doctorate with 2+ years. Experience preparing submission of CMC modules in eCTD format. Familiarity organizing responses to Health Authority requests. Familiarity with non-US regulatory submissions (bonus). Knowledge, Skills, & Abilities (Required/Desired) Knowledge of Health Authority procedures/guidance for document management and electronic submission. Knowledge of Health Authority CMC guidance documents and requirements. Proficient in Electronic Document Management Systems. Ability to meet deadlines; adapt to changing requirements. Strong organizational skills; written/oral communication; attention to detail. Knowledge of biologic-based drugs (cell/gene therapies, antibodies, recombinant proteins) desired. Application Instructions Application window anticipated to close 60 days from posting, or sooner if filled/closed. #J-18808-Ljbffr Scorpion Therapeutics