Global Regulatory Submissions Lead

CSL; Maidenhead; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

CSL is seeking a Senior Manager, Regulatory Submission to lead end-to-end regulatory submissions across global markets. You will supervise publishing activities, coordinate cross-functional teams, and manage vendor performance to ensure timely, compliant submissions.

This hands-on leadership role blends submission management, vendor oversight, planning, and process improvements with some publishing done by external partners.

Qualifications

• Bachelor's degree or higher in Life Sciences, Pharmacy, or related field.
• 5+ years regulatory experience with publishing or submission management.
• Familiarity with EU/US/Canada/Switzerland/Australia dossier standards and ICH guidelines.

Responsibilities

• Oversee external publishing and Global Submission Coordinator activities to ensure quality, compliance, and timelines.
• Manage vendor performance, resources, and continuity while evolving the global vendor operating model.
• Identify and elevate risks that could impact submission timelines or regulatory outcomes.
• Coordinate and prioritize regulatory submissions across portfolios and support submission planning.
• Oversee preparation, publishing, and submission of high-quality regulatory packages (eCTD, NEES, paper).
• Support submissions for NDA, BLA, IND, CTA, PSUR, Variations.
• Partner with Regulatory Project Managers to support submission strategy, planning, and execution.
• Provide submission planning support with Excel roadmaps and timelines when needed.

Skills

Regulatory submissions

Vendor management

Cross-functional collaboration

Regulatory publishing

Project management

Education

Bachelor's degree or higher in Life Sciences/Pharmacy

Tools

Veeva RIM

Job description

CSL is seeking a Senior Manager, Regulatory Submission to lead end-to-end regulatory submissions across global markets. You will supervise publishing activities, coordinate cross-functional teams, and manage vendor performance to ensure timely, compliant submissions.

This hands-on leadership role blends submission management, vendor oversight, planning, and process improvements with some publishing done by external partners.