Regulatory Submission Manager

BioSpace; King of Prussia (PA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

CSL Behring is seeking a Senior Manager, Regulatory Submission to lead global submission management activities and coordinate with Regulatory, Publishing, and cross-functional teams. You will oversee vendor relationships and ensure timely, compliant submissions across markets including NDA, BLA, IND, and variations.

The role requires 5+ years in regulatory affairs within pharma, experience with regulatory publishing, and familiarity with international dossier standards.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 5+ years of regulatory experience in the pharmaceutical industry.
• Experience with dossier preparation and regulatory submissions.
• Familiarity with EU/US/Canada/Switzerland/Australia dossier standards and ICH guidelines.
• Hands-on experience with electronic document management or regulatory information management systems (e.g., Veeva RIM).
• Experience working with external vendors or service providers; vendor management desirable.

Responsibilities

• Oversee external publishing and Global Submission Coordinator activities to meet quality, compliance, and timeline expectations.
• Manage vendor performance, resources, and standards; evolve the global vendor operating model.
• Identify and escalate risks impacting submission timelines or regulatory outcomes.
• Coordinate and prioritize regulatory submissions across portfolios and support planning.
• Oversee preparation, publishing, and submission of regulatory packages (eCTD, NDA/BLA/IND/CTA/Variations).
• 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 roadmaps and briefing timelines when needed.
• Ensure submissions meet technical format requirements and global standards.
• Monitor evolving publishing requirements and drive process improvements.

Skills

Regulatory submissions

Vendor management

Dossier preparation

Veeva RIM

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences 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.

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.

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 How CSL Supports Your Well-being | CSL.

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.