Senior Manager Regulatory Affairs

1d1 day ago

Bristol Myers Squibb

US · Full-time · $149,860 – $181,595

About this role

At RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, we seek an experienced Senior Manager in Regulatory Affairs. Reporting to the Head of Regulatory Affairs, you will oversee clinical and nonclinical regulatory functions as Global Regulatory Lead. This role shapes regulatory strategy for transformative radiopharmaceutical therapies.

You will lead the preparation and submission of regulatory filings including INDs, amendments, CTAs, and marketing applications. Preparation for health authority interactions and generation of required regulatory documents are key responsibilities. You will maintain expert knowledge of the relevant regulatory landscape and disease areas.

You will work with cross-functional teams to communicate regulatory strategies and upcoming program submissions. RayzeBio operates as a standalone entity within BMS, preserving its biotech culture while leveraging best-in-class oncology capabilities. Collaboration is at the heart of everything we do.

This role offers the opportunity to make an immediate impact on our science, our teams, and patients. RayzeBio aims to be the global leader in radiopharmaceuticals, developing innovative drugs against solid tumor targets. You will join a multidisciplinary team where your ideas are valued and expertise amplified.

Requirements

Bachelor's degree or higher
5 or more years of hands-on regulatory experience
Clinical regulatory strategy experience in oncology is a distinct advantage
Demonstrable record of strong leadership and teamwork in a cross-functional industry environment
Experience with radiopharmaceutical therapy is a plus
Excellent written and verbal communication skills
Highly organized with the ability to multitask and handle pressure well
Meticulous attention to detail

Responsibilities

Serve as Global Regulatory Lead for assigned programs
Develop regulatory strategy including timing and nature of global regulatory interactions
Lead preparation and submission of regulatory filings such as INDs, CTAs, and marketing applications
Lead preparation for health authority interactions and generate required regulatory documents
Communicate regulatory strategies and upcoming submissions to cross-functional teams
Maintain expert knowledge of the relevant regulatory landscape and anticipate changes in standard of care
Represent the company in relationships with regulators

Benefits

Opportunity to work as part of RayzeBio, a standalone entity within Bristol Myers Squibb, maintaining a biotech culture with access to global oncology expertise
Make an immediate impact on the development of transformative radiopharmaceutical therapies for cancer patients
Join a multidisciplinary team where ideas are valued and collaboration is central
Leverage best-in-class oncology capabilities of Bristol Myers Squibb