Global eCTD Submissions Project Lead – Remote

Eliassen Group; Honolulu (HI); On-site; USD 90,000 - 103,000; Part 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 role focuses on Modules 1-5 content planning, and coordination of global submissions across geographies to ensure evolving eCTD compliance.

The role reports to the Head of Regulatory Operations Clinical and Publishing for Global Submissions and may assist with secondary publishing as workload demands.

Qualifications

• 7+ years of direct regulatory experience in pharma with strong regulatory operations background.
• Proven global eCTD submission planning and management across Modules 1-5 and regions (US, EU, Canada).
• Experience with Veeva Vault RIM.
• Strong project management skills.
• Knowledge of drug development processes and regulatory strategies.
• Excellent written, spoken, and presentation communication.
• Ability to work with global teams and manage after-hours support.

Responsibilities

• Lead regulatory operations for registration planning and execution, including status updates and department planning.
• Manage global submissions across CTD modules and submission types (including Ad Promo, INDs, NDA/BLA, MAAs).
• Coordinate with regional teams to incorporate local agency requirements.
• Guide internal teams on submission processes and keep electronic records complete and timely.
• Oversee routine regulatory submissions (DSUR, NDA/BLA annual reports, PSUR/PADER).
• Support secondary publishing for eCTD content when needed.

Skills

Regulatory operations

Project management

Written and verbal communication

Teamwork/adaptability

Education

BS in chemistry, biology or 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. This remote role focuses on Modules 1-5 content planning, and coordination of global submissions across geographies to ensure evolving eCTD compliance.

The role reports to the Head of Regulatory Operations Clinical and Publishing for Global Submissions and may assist with secondary publishing as workload demands.