Global Regulatory Submissions Lead

Csl; Maidenhead; Hybride; GBP 90 000 - 120 000; Plein temps

Résumé du poste

CSL Behring in Maidenhead, UK seeks a Senior Manager, Regulatory Submission to lead global regulatory submissions, publish packages, and manage external vendors. The role combines hands-on submission activities with strategic oversight to ensure quality and timeliness across markets.

You will partner with Regulatory, Project Management, Publishing, and cross-functional teams to drive submission strategy, planning, and execution, while maintaining rigorous regulatory standards and timelines.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Pharmacy, or related field.
• 5+ years regulatory experience in pharma, with publishing or submission management preferred.
• Experience with dossier preparation for core and international markets.
• Familiarity with EU/US/Canada submissions and ICH guidelines.

Responsabilités

• Oversee external publishing and Global Submission Coordinator activities, ensuring work is delivered according to quality, compliance, and timeline expectations.
• Manage vendor performance, resource allocation, operational standards, and business continuity while contributing to the evolution of the global vendor operating model.
• Identify, assess, and elevate risks that could impact submission timelines or regulatory outcomes.
• Coordinate and prioritize regulatory submissions across portfolios and support submission planning activities.
• Oversee the preparation, publishing, and submission of high-quality regulatory packages, including eCTD, NEES, and paper submissions for investigational, marketing authorization, lifecycle management, and post-approval applications.
• Support submissions for a range of regulatory applications, including NDA, BLA, IND, CTA, PSUR, and Variations.
• Partner with Regulatory Project Managers and cross-functional teams to support submission strategy, planning, and execution.
• Provide submission planning support, including Excel-based roadmaps, storyboards, and briefing book timelines when a dedicated Submission Project Manager is not assigned.
• Ensure regulatory submissions meet technical format requirements, global standards, quality expectations, and applicable timelines.
• Monitor evolving regulatory publishing requirements and contribute to continuous improvement of global submission processes and standards.

Connaissances

Regulatory submission

Vendor management

Cross-functional collaboration

Regulatory publishing

Project leadership

Formation

Bachelor’s degree or higher in Life Sciences or related field

Outils

Veeva RIM

Description du poste

CSL Behring in Maidenhead, UK seeks a Senior Manager, Regulatory Submission to lead global regulatory submissions, publish packages, and manage external vendors. The role combines hands-on submission activities with strategic oversight to ensure quality and timeliness across markets.

You will partner with Regulatory, Project Management, Publishing, and cross-functional teams to drive submission strategy, planning, and execution, while maintaining rigorous regulatory standards and timelines.