Global Regulatory Submissions Lead

CSL; King of Prussia (PA); Hybrid; USD 140,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

CSL's Regulatory Submission Management team is seeking a Senior Manager to lead global submissions across NDA/BLA/IND and lifecycle programs. You will coordinate with Regulatory, Project Management, Publishing, and external partners to ensure timely, high-quality submissions in line with international standards.

This hands-on leadership role combines submission management, vendor oversight, and process improvement, with hybrid work and 3 onsite days as described.

Qualifications

• Bachelor's degree or higher in Life Sciences, Pharmacy, or a related field.
• 5+ years of regulatory experience in the pharmaceutical industry.
• Experience with dossier preparation and international submissions.
• Familiarity with local health authority dossier standards across markets such as EU, US, Canada, Switzerland, and Australia, as well as 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 regulatory submission processes, publishing requirements, quality standards, and timelines.
• Strong organizational and communication skills; ability to manage multiple priorities across geographies.

Responsibilities

• Oversee external publishing and Global Submission Coordinator activities.
• Manage vendor performance, resource allocation, operational standards, and business continuity.
• 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 preparation, publishing, and submission of regulatory packages (eCTD, NEES, and paper submissions).
• Support submissions for NDA, BLA, IND, CTA, PSUR, and Variations.
• Partner with Regulatory Project Managers and cross-functional teams to support strategy, planning, and execution.
• Provide submission planning support, including Excel-based roadmaps and timelines.
• Ensure regulatory submissions meet technical format requirements, global standards, and timelines.
• Monitor evolving regulatory publishing requirements and drive process improvements.

Skills

Regulatory publishing

Submission management

Vendor management

Dossier preparation

Cross-functional collaboration

Regulatory knowledge

Veeva RIM

People leadership

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva RIM

Job description

CSL's Regulatory Submission Management team is seeking a Senior Manager to lead global submissions across NDA/BLA/IND and lifecycle programs. You will coordinate with Regulatory, Project Management, Publishing, and external partners to ensure timely, high-quality submissions in line with international standards.

This hands-on leadership role combines submission management, vendor oversight, and process improvement, with hybrid work and 3 onsite days as described.