Manager, Regulatory Operations and Publishing

Bristol Myers Squibb; United States; On-site; USD 130,000 - 170,000; Full time

Job summary

RayzeBio, a Bristol Myers Squibb subsidiary focused on radiopharmaceuticals in oncology, seeks a Manager of Regulatory Operations and Publishing. You will oversee submission activities, format and QC documents, and coordinate with Regulatory Affairs, Clinical, Nonclinical, CMC and Quality to ensure submission readiness.

Proficiency in Veeva RIM and eCTD standards is essential, with 4+ years in Regulatory Operations and a Bachelor’s degree.

Qualifications

• Bachelor's degree or higher required.
• 4+ years of Regulatory Operations experience.
• Proficiency in Word, PDF publishing, eCTD structure and regulatory documents standards.
• Experience with Veeva RIM and Accenture StartingPoint preferred.

Responsibilities

• Oversee daily submission activities ensuring compliance and timeliness.
• Format, generate, and QC submission documents per eCTD and regulatory standards.
• Coordinate with external vendors and internal teams to support submission readiness.
• Manage reference systems like Veeva Vault RIM.

Skills

Detail-oriented

Organizational skills

Troubleshooting

Effective communicator

Independent worker

Collaborative mindset

Education

Bachelor's degree

Tools

Veeva Vault RIM

Accenture StartingPoint

Microsoft Word

PDF publishing

Job description

Role

Manager of Regulatory Operations and Publishing supporting regulatory submissions for RayzeBio, a Bristol Myers Squibb subsidiary focused on radiopharmaceuticals in oncology.

Responsibilities

• oversee daily submission activities ensuring compliance and timeliness;
• format, generate, and QC submission documents according to eCTD and regulatory standards;
• coordinate with external vendors and internal teams (Regulatory Affairs, Clinical, Nonclinical, CMC, Quality) to support submission readiness;
• manage reference systems like Veeva Vault RIM;
• develop and improve SOPs and templates;
• maintain knowledge of FDA, ICH, and electronic submission standards.

Requirements

• Bachelor's degree;
• 4+ years of Regulatory Operations experience;
• proficiency in Word, PDF publishing, eCTD structure, and regulatory document standards;
• experience with Veeva RIM and Accenture StartingPoint preferred.

Skills

detail-oriented, strong organizational and troubleshooting abilities, effective communicator, independent worker, collaborative mindset.

High-Value

• regulatory submission expertise in oncology radiopharmaceuticals;
• focus on electronic submission standards;
• cross-functional collaboration;
• remote work setup.