Regulatory Submission Manager

CSL Plasma; King of Prussia (PA); Hybrid; USD 150,000 - 190,000; Full time

Job summary

CSL Plasma in King of Prussia, PA is seeking a Senior Manager, Regulatory Submission. This hybrid role teams with Global Regulatory Submission Management to ensure timely, high-quality regulatory submissions across markets.

You will coordinate with Regulatory, Project Management, Publishing, cross-functional groups and external partners to manage risks and uphold global standards. You will guide planning, publishing, and submission activities for NDA, BLA, IND, CTA, PSUR, and Variations,

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or related field.
• 5+ years regulatory experience in pharmaceutical industry.
• Experience with dossier preparation and regulatory submissions.
• Familiarity with EU, US, Canada, Switzerland, and Australia dossier standards and ICH guidelines.
• Experience working with external vendors or service providers.

Responsibilities

• Oversee external publishing and Global Submission Coordinator activities to meet quality, compliance, and timeline expectations.
• Manage vendor performance, resource allocation, and standards, contributing to 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 activities.
• Oversee preparation, publishing, and submission of regulatory packages including eCTD, NEES, and paper submissions across stages.
• Support submissions for NDA, BLA, IND, CTA, PSUR, and Variations across markets.
• Partner with Regulatory Project Managers and cross-functional teams to support strategy, planning, and execution.
• Provide submission planning support with Excel roadmaps, storyboards, and briefing timelines when needed.
• Ensure submissions meet technical format requirements, global standards, and timelines.
• Monitor evolving regulatory publishing requirements and drive process improvements.

Skills

Regulatory expertise

Project coordination

Cross-functional collaboration

Vendor management

People leadership (bonus)

Education

Bachelor's degree or higher in Life Sciences, Pharmacy, or related field

Tools

Veeva RIM

Job description

Senior Manager, Regulatory Submission

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.

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.

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 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.

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.

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