Manager, Regulatory Operations and Publishing

At RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, we blend the agility of an emerging biotech with the global resources of a leading oncology innovator. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for cancer patients. Join a multidisciplinary team where collaboration and impact are at the core of our work.

About the role

Manage day-to-day regulatory submission operations to ensure high-quality, timely, and compliant health authority submissions. This role supports the creation and maintenance of regulatory documents and submissions, working closely with cross-functional teams and external vendors.

Responsibilities

• Manage day-to-day regulatory submission operations activities to ensure high-quality, timely, and compliant health authority submissions.
• Format complex documents according to company standards to optimize PDF rendering and limit manual publishing.
• Generate submission-ready PDFs in compliance with regulatory guidance, eCTD requirements, and internal PDF publishing standards.
• Perform technical QC of submission documents and published submissions to ensure accuracy, consistency, completeness, and compliance.
• Manage submission execution activities, including deliverable tracking, timeline coordination, and submission readiness assessments.
• Coordinate with Regulatory Affairs and cross-functional stakeholders to ensure timely submission delivery.
• Collaborate with external submission vendors to support timely and high-quality submission delivery.
• Provide technical support to authoring teams on the use of StartingPoint templates.
• Support reference management activities, including maintaining references in EndNote or other tools.
• Partner with Regulatory Affairs, Clinical, Nonclinical, CMC, Medical Writing, Quality, and external vendors to resolve formatting, publishing, and QC issues.
• Support creation and maintenance of data, records, and documents in Veeva Vault RIM and other systems.
• Support development and continuous improvement of Regulatory Operations SOPs, work instructions, templates, checklists, and submission standards.
• Maintain current knowledge of FDA, ICH, and other applicable regulatory requirements related to electronic submissions and document standards.

Requirements

• Bachelor’s degree with 4+ years of Regulatory Operations experience.
• Experience with Accenture StartingPoint Templates and Veeva RIM preferred.

Skills

• Demonstrated expertise in Microsoft Word formatting, PDF publishing, and submission document preparation.
• Strong understanding of eCTD submission structure, PDF specifications, bookmarks, hyperlinks, file naming, and submission-ready document standards.
• Experience performing technical quality control of regulatory submissions and published eCTD sequences.
• Highly detail-oriented, with a strong focus on accuracy, consistency, and quality.
• Strong organizational skills, with the ability to manage multiple concurrent submissions and competing priorities.
• Ability to troubleshoot complex document formatting and PDF publishing issues.
• Ability to work independently and follow tasks through from start to finish.
• Strong communication and interpersonal skills.
• Ability to collaborate effectively with internal teams and external vendors.
• Proactive, professional, and confident.
• Excellent professional ethics and integrity.

Physical Demands

• Regularly required to sit, reach with hands and arms, and talk or hear.
• Occasionally required to lift and/or move up to 15 pounds.
• Specific vision abilities required include close vision and distance vision.

Pay

Remote - United States - US $134,505 - $162,988 (full-time employee basis). Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation will be determined based on demonstrated experience.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support Programs: 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:
  • Paid Time Off for US Exempt Employees: Flexible time off (unlimited, with manager approval) and 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or RayzeBio employees).
  • Paid Time Off for 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.
  • Additional time off based on eligibility: 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 Year’s Day.