Senior Manager, Regulatory Affairs

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.

 

Job Responsibilities

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

• 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.

 

Basic Qualification:

• 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

 

Skills:

• 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

 

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Remote - United States - US: $149,860 - $181,595

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, a