Senior Manager, Regulatory Affairs

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 is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC).  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 Manager in Regulatory Affairs. This position will report to the Sr. Director of Regulatory Affairs and will oversee and/or manage clinical and nonclinical regulatory functions within RayzeBio. Responsibility expectations will be commensurate with experience. This is a remote-based role.

Responsibilities:

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

• Serves as Global Regulatory Lead (GRL)

• Regulatory strategy, including timing and nature of global regulatory interactions.

• US Labeling Lead and Company Core Data Sheet (CCDS Lead); lead Label Working Group (LWG) to execute strategy in alignment with company and program goals.

• Generation of regulatory documents that are required for regulatory interactions.

• Keeping up to date in the relevant disease areas, including anticipating changes in standard of care as perceived by regulatory authorities and other key customers.

• Maintaining an expert knowledge of the relevant regulatory landscape.

• Maintaining a relationship with and representing the company to regulators.

• Lead the preparation and submission of regulatory filings (e.g., IND, IND amendments, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).

• Lead the preparation for Health Authority Interactions.

Education and Experience

• Bachelor’s degree or higher

• 5 or more years of hands-on regulatory experience, experience of clinical regulatory strategy in oncology would be a distinct advantage.

• Demonstrable record of strong leadership and teamwork in a cross-functional industry environment.

• Demonstrated knowledge of US Labeling Lead and Company Core Data Sheet (CCDS Lead); led Label Working Group (LWG) to execute strategy in alignment with company and program goals.

• Experience working as a Global Regulatory Lead (GRL)

Skills and Qualifications:

• Excellent written and verbal communication skills.

• Highly organized, with the ability to multi-task and handle pressure well

• Meticulous with detail and precision

• Ability to think through a project or task of diverse complexity and execute independently from beginning to end

• Fully proficient in MS Office (Outlook, Word, PowerPoint, Excel, and Teams) and video conferencing

• Strong communication and interpersonal skills

• Should be assertive, proactive, professional, and confident

• Excellent professional ethics and integrity

• Flexibility to adapt in a cross-functional and dyn