The primary responsibilities of this role, Senior Regulatory CMC Strategist (Senior Director), are to: Represent Regulatory CMC and lead matrix teams for cell therapy programs, including participation in development and global regulatory teams across therapeutic areas; Develop and implement robust, innovative CMC strategies for cell and gene therapy programs, providing guidance on regulatory requirements for clinical trial and marketing applications; Lead CMC-related Health Authority interactions, including briefing documents, responses to questions, submissions, and resolution of regulatory issues; Partner closely with CMC, Analytical Development, Quality, Nonclinical, Clinical, Regulatory Strategy, and Quality Assurance teams to support compliant development and submissions; Identify, assess, escalate, and propose solutions for major, routine, and complex regulatory risks, deficiencies, change controls, and strategic issues. Bayer seeks an incumbent who possesses the following: Required Qualifications: Advanced scientific degree (e.g., PhD, MSc, PharmD); Biotech or pharmaceutical industry experience including relevant regulatory CMC experience with development of biologics (cell therapy required, gene therapy a plus), and US and global submissions; The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development; Extensive experience in preparing quality sections of regulatory filings including global Health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs following eCTD format.