Director, Regulatory Operations

Bristol Myers Squibb

1d • 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/ 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.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• 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.

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: Director