Senior Manager, Regulatory Submission

Regulatory Jobs; King of Prussia (PA); Hybrid; USD 130.000 - 170.000; Vollzeit

Benefits dieser Stelle

Hybrid work arrangement

Zusammenfassung

CSL Behring is seeking a Senior Manager, Regulatory Submission to lead global submission activities across markets. You will coordinate with Regulatory, PM, Publishing, and cross-functional teams to ensure timely, high-quality submissions and oversee external publishing partners.

You will manage risks, align with global standards, and support planning, execution, and continuous improvement of submission processes within a hybrid work model.

Qualifikationen

• Bachelor's degree in Life Sciences or related field is required.
• 5+ years of regulatory experience in the pharmaceutical industry.
• Experience with regulatory dossiers and submissions for core and international markets.
• Familiarity with EU, US, Canada, Switzerland, and Australia dossier standards and ICH guidelines.
• Hands-on experience with electronic document management systems such as Veeva RIM.
• Experience working with external vendors or service providers; vendor management is desirable.
• Strong understanding of submission processes, publishing requirements, and timelines.
• Excellent organizational and communication skills across functions and geographies.

Aufgaben

• Oversee external publishing and Global Submission Coordinator activities to meet quality, compliance, and timelines.
• Manage vendor performance, resources, operational standards, and business continuity.
• Identify, assess, and escalate risks affecting submission timelines or outcomes.
• Coordinate and prioritize regulatory submissions across portfolios and plan submissions.
• Oversee preparation, publishing, and submission of regulatory packages (eCTD, NEES, paper).
• Support submissions for NDA, BLA, IND, CTA, PSUR, Variations across markets.
• Partner with Regulatory Project Managers and cross-functional teams on strategy and execution.
• Provide planning support with Excel roadmaps, timelines, and briefing books when needed.
• Ensure submissions meet format, standards, and timelines; monitor evolving publishing requirements.

Kenntnisse

Regulatory submission management

Vendor oversight

Regulatory publishing

Cross-functional collaboration

Project planning

People leadership

Ausbildung

Bachelor's degree in Life Sciences or related field

Tools

Veeva RIM

Jobbeschreibung

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.

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.

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About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit https://www.csl.com/.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.