Senior Manager, Regulatory Affairs

Bristol Myers Squibb • San Diego, CA

4d • 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/ Job Description We are seeking an experienced and innovative Senior Manager in Regulatory Affairs (clinical and nonclinical). This Global Regulatory Lead (GRL) position will report to the Sr. Director of Regulatory Affairs and will oversee and/or manage regulatory functions and direct reports within RayzeBio. Responsibility expectations will be commensurate with experience.

Requirements

• Bachelor’s degree or higher
• 5 or more years of hands-on regulatory experience
• Experience with therapeutic and diagnostic (imaging) radiopharmaceutical product development and familiarity with radioisotopes such as 68Ga, 177Lu, 225Ac, 161Tb, F18, Y90, etc.
• Experience with nonclinical and clinical regulatory strategy in oncological indications
• Demonstrable record of strong leadership and teamwork in a cross-functional, fast-paced 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

Responsibilities

• Global Regulatory Lead for a cutting edge RPT programs
• Clinical and nonclinical regulatory strategy for therapeutic and diagnostic (imaging) products, including timing and nature of global regulatory interactions.
• Authoring 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.

Benefits

• 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.

What This Job Offers

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