Senior Director, Regulatory CMC

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Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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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 Sr. Director in Regulatory Affairs - CMC. This position will report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions and direct report(s) within RayzeBio. Responsibility expectations will be commensurate with experience.

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

• Responsible for working with the CMC teams to guide the CMC global regulatory strategy for RayzeBio radiopharmaceuticals leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), Drug Master Files (DMFs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions.

• Participate in development and execution of global CMC regulatory strategies and development of cold kits and/or diagnostics.

• Responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions (e.g., IND, IMPD, facility DMF, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards

• Prepare Health Authority responses & background packages (including participating/leading Health Authority meetings); and/or post-approval submissions

• Independently manage and prioritize multiple complex projects

• Manage and maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work

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

• Support Manufacturing Change Controls for global impact and guide technical teams on global change management

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

• Provide ac hoc Regulatory-CMC support to RayzeBio manufacturing team

• Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements

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

• Review and guide content of CMC information in nonclinical and clinical documents including clinical protocols, pharmacy manuals, investigator brochures, and prescribing information

• Communicate critical issues to Management

Basic Qualifications:

• Bachelor’s degree in chemistry is highly desired

• 9 or more years of hands-on CMC regulatory experience, title dependent upon experience

• Previous experience with radiopharmaceutical therapy (therapeutic and diagnostic), radiopharmaceutical cold kits, and/or PET drug products is a must.

• Prior experience in independently authoring IND, IMPD, NDA, MAA and/or DMF CMC sections is required

• Understanding of phase-appropriate data requirements for regulatory filing