Senior Manager, Regulatory Submission

CSL; Philadelphia (Philadelphia County); Hybride; USD 150 000 - 190 000; Plein temps

Résumé du poste

CSL in the Philadelphia area is seeking a Senior Manager, Regulatory Submission to lead global submission activities, coordinate cross-functional teams, and ensure high-quality, timely packages (eCTD, NDA/BLA) across markets.

You will oversee external publishing partners, manage vendors, assess risks to timelines, and help shape submission strategy while maintaining compliance with global standards and regulatory guidelines.

Qualifications

• 5+ years of regulatory experience in pharma, with publishing or submission management
• Experience with regulatory submissions in core and international markets
• Familiarity with EU/US/Canada/Switzerland/Australia dossier standards and ICH guidelines
• Experience working with external vendors or service providers
• Experience leading teams or functions in submission management

Responsabilités

• Oversee external publishing and Global Submission Coordinator activities, ensuring quality, compliance, and timelines.
• Manage vendor performance, resources, and continuity while evolving the global vendor model.
• Identify and escalate risks potentially impacting timelines or regulatory outcomes.
• Coordinate and prioritize regulatory submissions across portfolios; support planning.
• Oversee preparation, publishing, and submission of regulatory packages (eCTD, NEES, paper).
• Support submissions for NDA, BLA, IND, CTA, PSUR, and Variations.
• Partner with Regulatory Project Managers to support strategy, planning, and execution.
• Provide submission planning support with roadmaps, storyboards, and timelines.
• Ensure submissions meet format, standards, and timelines; drive continuous improvement.
• Monitor evolving publishing requirements and refine processes.

Connaissances

Regulatory submissions

Vendor management

Regulatory publishing

Submission planning

Cross-functional collaboration

Regulatory strategy

Leadership

Formation

Bachelor’s degree or higher in Life Sciences/Pharmacy

Outils

Veeva RIM

Description du poste

Locations: King of Prussia, PA | Glattburgg, Switzerland | Maidenhead, UK

Work Arrangement: Hybrid - 3 days onsite

Reports to: Global Submission Management Lead

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a strong focus on collaboration, we're building a future-ready organization that thrives in dynamic biotech ecosystems. Join CSL and become part of an agile team committed to developing therapies that make a meaningful difference for patients around the world.

The Opportunity

Could you be our next Senior Manager, Regulatory Submission?

As a key member of the Global Regulatory Submission Management Team, you will help ensure the timely, high-quality, and compliant delivery of regulatory submissions across global markets. You will work closely with Regulatory, Project Management, Publishing, cross-functional teams, and external partners to coordinate submission activities, manage risks, and ensure adherence to global regulatory and publishing standards.

This is a hands-on leadership role that combines submission management, vendor oversight, regulatory publishing, planning, and process improvement. While much of the publishing activity is managed by external partners, you will provide oversight and may step in directly to publish or coordinate submissions when needed.

What You'll Do

• 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 escalation 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.

What You'll Bring

• Bachelor's degree or higher in Life Sciences, Pharmacy, or a related field.
• 5+ years of regulatory experience within the pharmaceutical industry, preferably with experience in regulatory publishing or submission management.
• Experience with dossier preparation and regulatory submissions for core and international markets.
• Familiarity with local health authority dossier standards across markets such as the EU, US, Canada, Switzerland, and Australia, as well as applicable ICH guidelines.
• Hands-on experience with electronic document management or regulatory information management systems, such as Veeva RIM.
• Experience working with external vendors, outsourced teams, or service providers; vendor management experience is highly desirable.
• Strong understanding of regulatory submission processes, publishing requirements, quality standards, and submission timelines.
• Strong organizational and communication skills, with the ability to manage multiple priorities and collaborate effectively across functions and geographies.
• Previous people leadership experience is a plus.

Why Join CSL?

At CSL, you'll have the opportunity to work at the intersection of science, innovation, and global regulatory strategy. You'll play an important role in helping bring innovative therapies to patients while working with talented colleagues and external partners across a global organization.