Global Regulatory Publishing Director – Submissions

Navitas Life Sciences Pvt. Ltd.; Maryland; On-site; USD 150,000 - 190,000; Full time

Job summary

Navitas Life Sciences Pvt. Ltd. seeks an Associate Director – Regulatory Publishing to lead end-to-end publishing for IND/NDA/MAA/BLA filings across multiple regions, ensuring timely eCTD submissions and lifecycle maintenance. The role requires strong project management and cross-functional leadership.

The candidate will coordinate with RA teams, drive process improvements, and mentor junior staff, delivering high-quality submissions with first-time-right accuracy.

Qualifications

• 15 to 20 years’ experience in regulatory publishing.
• Hands-on experience creating submission outputs for eCTD.
• Ability to understand agency requirements and timelines.
• Coordinating cross-functional teams for effective project execution.

Responsibilities

• Manage end-to-end Publishing support for IND/NDA/MAA/BLA submissions and lifecycle maintenance across regions.
• Lead cross-functional teams and coordinate with RA customers and internal teams.
• Ensure timely eCTD submissions and quality checks.
• Plan resources and manage submission timelines to meet delivery goals.
• Develop SOPs, workflows, and provide training and QC feedback.

Skills

Regulatory publishing

eCTD submissions

Project management

Cross-functional leadership

Team mentoring

Quality control

Regulatory submissions

Stakeholder coordination

Education

Life sciences degree

Job description

Navitas Life Sciences Pvt. Ltd. seeks an Associate Director – Regulatory Publishing to lead end-to-end publishing for IND/NDA/MAA/BLA filings across multiple regions, ensuring timely eCTD submissions and lifecycle maintenance. The role requires strong project management and cross-functional leadership.

The candidate will coordinate with RA teams, drive process improvements, and mentor junior staff, delivering high-quality submissions with first-time-right accuracy.