Regulatory Operations Lead: Global Submissions & RIM

Openkrill; United States; Remote; USD 145,000 - 175,000; Full time

Job summary

Parabilis Medicines in Cambridge, MA is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions and information management across development programs.

The role requires implementing Veeva RIM Basics, advancing publishing capabilities, and building scalable regulatory operations processes while collaborating with Regulatory Affairs, Medical Writing and Clinical Development.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 6+ years Regulatory Operations experience.
• Extensive experience supporting FDA electronic submissions.
• Strong knowledge of eCTD publishing and submission lifecycle management.
• Experience with Veeva Vault RIM or Veeva RIM Basics.
• Experience supporting regulatory information management systems.
• Experience supporting global submissions, including CTAs and Health Authority interactions.
• Experience training end users on regulatory systems.
• Experience developing Regulatory Operations processes and SOPs.
• Strong project management and organizational skills.
• Excellent communication and collaboration skills.
• Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected.

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 standardized document lifecycle management.
• Support the transition to an internal Regulatory Operations publishing model.
• Develop and maintain inspection-ready regulatory information supporting U.S. and global regulatory submissions.
• Partner with the Director of Regulatory Operations to modernize Regulatory Operations through technology and automation.

Skills

Regulatory Operations

Project management

Communication

AI tools

Education

Bachelor's degree in Life Sciences

Tools

Veeva Vault RIM

Veeva RIM Basics

Job description

Parabilis Medicines in Cambridge, MA is seeking a Senior Manager/Associate Director, Regulatory Operations to lead global regulatory submissions and information management across development programs.

The role requires implementing Veeva RIM Basics, advancing publishing capabilities, and building scalable regulatory operations processes while collaborating with Regulatory Affairs, Medical Writing and Clinical Development.