Remote Global eCTD Submissions Lead

Eliassen Group; Carson City (NV); On-site; USD 90,000 - 103,000; Part time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Life insurance

Job summary

Eliassen Group is seeking a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high-profile molecules. Remote contract role reporting to the Head of Regulatory Operations Clinical and Publishing for Global Submissions.

The role requires 7+ years in pharma regulatory operations, global submissions experience (US/EU/Canada), and familiarity with Veeva Vault RIM. Rate: $65.00–$75.00/hr (W2). Benefits include medical, dental, vision, and 401(k) matching.

Qualifications

• 7+ years of regulatory experience in pharma.
• Global eCTD submission planning across US/EU/Canada.
• Working knowledge of ICH guidelines.
• Experience coordinating cross-functional regulatory teams.

Responsibilities

• Lead regulatory submission planning and execution for modules 1-5.
• Coordinate global registrations and regulatory communications.
• Guide development teams on submission management processes.
• Support secondary publishing for eCTD submissions when needed.

Skills

Regulatory operations

Project management

Global eCTD planning

Cross-functional collaboration

ICH guidelines

Communication skills

Education

BS in chemistry/biology/pharmacy

Tools

Veeva Vault RIM

Job description

Eliassen Group is seeking a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high-profile molecules. Remote contract role reporting to the Head of Regulatory Operations Clinical and Publishing for Global Submissions.

The role requires 7+ years in pharma regulatory operations, global submissions experience (US/EU/Canada), and familiarity with Veeva Vault RIM. Rate: $65.00–$75.00/hr (W2). Benefits include medical, dental, vision, and 401(k) matching.