Senior Director, Regulatory Affairs - CMC

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RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

We are seeking an experienced and motivated Senior Director, Regulatory Affairs - CMC (Manufacturing). This position will report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in Indianapolis. Responsibility expectations will be commensurate with experience.

Responsibilities:

• Work with the Indianapolis facility teams (QA, QC, Operations, Manufacturing, Development, Validation, etc.) to provide on-site regulatory decision making and support for RayzeBio-manufactured radiopharmaceuticals to generate documentation leading to successful preparation and approval of Investigational New Drug applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), Drug Master Files (DMFs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions

• Lead the development and execution of global CMC regulatory strategies for activities conducted at the Indianapolis manufacturing facility

• Responsible for content development, compilation, maintenance, and review of the facility DMF and/or authoring the facility-based Quality Modules in regulatory applications (e.g., IND, IMPD, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards

• Work with the Indianapolis facility teams to ensure CMC documentation (e.g., protocols, reports, validation activities, specifications, analytical methods, batch records, etc.) that support development, process validation, tech transfer activities, and facility controls meet regulatory standards

• Prepare Health Authority responses & background packages (including participating/leading Health Authority meetings)

• Author and prepare submissions for post-approval manufacturing changes (annual reports, CBEs, PAS, supplements)

• Independently manage and prioritize multiple complex projects, programs and workload.

• Manage and maintain strong working relationships with the Indianapolis facility teams, remote and SD teams, participate in and/or lead multifunctional teams

• Manage Regulatory Affairs – CMC staff

• Assess manufacturing Change Controls for global impact and guide technical teams on global change management

• Provide additional ad hoc Regulatory-CMC support to RayzeBio manufacturing team

• Research and provide analysis of current US and international regulations and guidance

• Actively participate with Global Regulatory Leads to develop content of container labels

• Communicate critical issues to Leadership

Basic Qualifications:

• Bachelor’s degree with 10 or more years of hands-on regulatory CMC experience OR an advanced degree with at least 7 years of hands-on regulatory CMC experience

• Experience with independently authoring IND, IMPD, NDA, MAA and/or DMF CMC sections

• Experience providing on-site regulatory strategy in collaboration with facility teams (QA, QC, Operations, Manufacturing, Development, Validation, etc.) to generate documentation leading to IND, IMPD, DMF, NDA and MAA applications.