Director, Regulatory Affairs - CMC

Working with Us
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 rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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

Job Responsibilities

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

• Director, Regulatory Chemistry, Manufacturing and Controls (CMC) will be 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

• 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

Education and Experience:

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

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

• Understanding of phase-appropriate data requirements for regulatory filings is desired

• Experience with complex aseptic formulations is essential

• Demonstrable record of strong leadership a