Remote Regulatory Submissions & Publishing Lead

Bristol Myers Squibb; United States; Teletrabalho; USD 130 000 - 170 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Detail-oriented

Organizational skills

Troubleshooting

Effective communicator

Independent worker

Collaborative mindset

Formação académica

Bachelor's degree

Ferramentas

Veeva Vault RIM

Accenture StartingPoint

Microsoft Word

PDF publishing

Descrição da oferta de emprego

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.