Regulatory Operations Lead: Global Submissions & RIM

Talanto; Cambridge (MA); On-site; USD 145,000 - 175,000; Full time

Job summary

Parabilis is seeking a Senior Manager/Associate Director, Regulatory Operations to drive regulatory success and shape development of life-changing treatments. You will lead global regulatory submissions, information management, publishing, and Health Authority interactions across programs.

The role requires strong Regulatory Operations expertise, systems implementation experience, and a passion for process improvement, collaborating with Regulatory Affairs, Medical Writing, Clinical Development,

Qualifications

• Bachelor's degree in Life Sciences or related discipline, or equivalent.
• Approximately 6-10 years of Regulatory Operations experience in biotech/pharma.
• Experience supporting FDA electronic submissions.

Responsibilities

• Provide operational leadership supporting global regulatory submissions from planning through archival.
• Serve as the business lead for Regulatory Information Management and Veeva RIM Basics.
• Partner with cross-functional stakeholders to implement document lifecycle management.
• Support transition to an internal Regulatory Operations publishing model.
• Develop and maintain inspection-ready regulatory information for US/global submissions.
• Collaborate with the Director to modernize Regulatory Operations through tech and automation.

Skills

Regulatory Ops

FDA submissions

eCTD publishing

AI tools usage

Project management

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related

Tools

Veeva Vault RIM

Veeva RIM Basics

Job description

Parabilis is seeking a Senior Manager/Associate Director, Regulatory Operations to drive regulatory success and shape development of life-changing treatments. You will lead global regulatory submissions, information management, publishing, and Health Authority interactions across programs.

The role requires strong Regulatory Operations expertise, systems implementation experience, and a passion for process improvement, collaborating with Regulatory Affairs, Medical Writing, Clinical Development,