Sr. Manager Regulatory Affairs

Bristol Myers Squibb

1d • $149,860 - $181,595 • Remote

About The Position

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ 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), breast cancer, hepatocellular carcinoma (HCC). Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Requirements

• 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.
• 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 dynamic environment
• Applies AI to improve team execution and decision‑making

Nice To Haves

• Radiopharmaceutical therapy is a plus.

Responsibilities

• Serves as Global Regulatory Lead (GRL)
• Regulatory strategy, including timing and nature of global regulatory interactions.
• Work with cross-functional teams to communicate regulatory strategies and upcoming program submissions/interactions.
• Lead the preparation and submission of regulatory filings (e.g., IND, IND amendments, Diversity Plans, CTA/IMPD, annual report, briefing document, iPSP/PIP, safety reports, marketing applications).
• Lead the preparation for Health Authority Interactions.
• 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.

Benefits

• Medical, pharmacy, dental, and vision care.
• Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager