Remote Global Regulatory Operations Lead (eCTD)

Eliassen Group; Cheyenne (WY); On-site; USD 90,000 - 103,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401(k) with company matching

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. This remote, contract role interfaces with global teams and requires strong regulatory operations expertise and PM skills.

Responsibilities include coordinating submissions across modules and regions, ensuring compliance with evolving eCTD requirements, and supporting secondary publishing as workload allows. Willingness to work ET hours is needed.

Qualifications

• 7+ years of direct regulatory experience in pharma with strong clinical Regulatory Operations background.
• Global eCTD submission planning and management experience across Modules 1-5 and regions including US, EU, and Canada; working knowledge of ICH guidelines.
• Experience with Veeva Vault RIM.
• Strong project management skills.
• Knowledge of drug development processes and regulatory or business strategies and plans.
• Effective written, spoken, and presentation communication.
• Demonstrated teamwork and adaptability to diverse interpersonal styles.
• Ability to provide secondary publishing support for eCTD submissions when required.
• Ability to work a standard Monday through Friday schedule on Eastern Time, with flexibility to support after-hours and some weekends in coordination with global teams.

Responsibilities

• Lead global eCTD submissions planning and management for Modules 1-5.
• Coordinate cross-regional submissions and urgent authority requests.
• Partner with global teams to incorporate local agency regulations and plan submissions in regions adopting eCTD specifications.
• Guide development teams on internal and agency registration management processes.
• Own registration management at molecule or project level; track status and regulatory communications.
• Support routine submissions such as DSUR, NDA/BLA annual reports, PSUR/PADER, and maintenance submissions.
• Assist with secondary publishing needs as workload demands.

Skills

Regulatory Operations

Global eCTD

Veeva Vault RIM

Project Management

Drug Development

Communication

Teamwork

Secondary Publishing

Education

BS in chemistry/biology/pharmacy

Job description

Eliassen Group is seeking a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high profile molecules. This remote, contract role interfaces with global teams and requires strong regulatory operations expertise and PM skills.

Responsibilities include coordinating submissions across modules and regions, ensuring compliance with evolving eCTD requirements, and supporting secondary publishing as workload allows. Willingness to work ET hours is needed.