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Bristol Myers Squibb

Senior Manager, Regulatory Affairs

Bristol Myers Squibb

Senior Manager in Regulatory Affairs at RayzeBio overseeing clinical and nonclinical regulatory functions. Reporting to the Head of Regulatory Affairs and leading regulatory strategy and submissions.

Posted 6/2/2026full-timeRemote • California • 🇺🇸 United StatesSenior💰 $149,860 - $181,595 per yearWebsite

About the role

Key responsibilities & impact
  • 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.

Requirements

What you’ll need
  • 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.
  • Radiopharmaceutical therapy is a plus.
  • 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

Benefits

Comp & perks
  • Health Coverage: Medical, pharmacy, dental, and vision care.
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
  • Financial Well-being and Protection: 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.
  • Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
  • Based on eligibility*, additional time off for employees may include 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.
  • All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

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Hard Skills & Tools
regulatory strategyregulatory filingsINDCTAsafety reportsregulatory documentsclinical regulatory strategyradiopharmaceutical therapyproject executionAI application
Soft Skills
leadershipteamworkcommunicationorganizationmulti-taskingattention to detailindependenceassertivenessprofessionalismflexibility
Certifications
Bachelor’s degreehigher degree