Director, Regulatory Operations

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/

We are seeking an experienced Director of Regulatory Operations, reporting to the Head of Regulatory Affairs or designee. This position will lead regulatory operations and future direct reports within RayzeBio. Responsibility expectations will be commensurate with experience. This role has the option for Remote.

Job Responsibilities

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

• Build and manage a Regulatory Operations team to support submission planning, publishing, and lifecycle management.
• Oversee/lead planning, tracking, publishing, compilation, and archiving efforts in support of regulatory submission activities including INDs, NDAs, BLAs, IND amendments, IMPDs and CTA submissions, EU and Rest of World (ROW) submissions.
• Lead the implementation and optimization of Veeva Vault RIMs, ensuring alignment with regulatory and business needs.
• Establish and maintain SOPs, work instructions, and best practices for regulatory operations.
• Monitor global regulatory operations requirements and ensure compliance with evolving standards.
• Serve as the primary liaison with publishing vendors, as needed, to ensure compliant electronic submissions.
• Manage templates and guidelines for documentation to be included in regulatory submissions; provide formatting assistance and training across functional groups.

 

Education and Experience

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Minimum of 7+ years in Regulatory Operations within the pharmaceutical or biotech industry.
• Proven experience implementing and managing Veeva Vault RIMs or similar regulatory systems.
• Strong knowledge of global regulatory submission formats (eCTD, NeeS, paper) and requirements.
• Demonstrated success in leading submissions across US, EU, and global markets.
• Experience building and scaling teams in a high-growth, agile environment.
• Excellent project management, communication, and leadership skills.
• Ability to thrive in a fast-paced, dynamic setting with shifting priorities.

 

Skills and Qualifications

• Experience with regulatory publishing tools and document management systems.
• Familiarity with regulatory intelligence platforms and submission tracking tools.
• Strong understanding of regulatory lifecycle management and compliance frameworks.
• 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: $210,572 - $255,164

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, and experience. Final, individual compensation will be deci