Global Regulatory Submissions Lead (Hybrid, 3 days onsite)

CSL; Philadelphia (Philadelphia County); Hybrid; USD 150,000 - 190,000; Full time

Job summary

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

Responsibilities

• 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.

Skills

Regulatory submissions

Vendor management

Regulatory publishing

Submission planning

Cross-functional collaboration

Regulatory strategy

Leadership

Education

Bachelor’s degree or higher in Life Sciences/Pharmacy

Tools

Veeva RIM

Job description

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.