Senior Regulatory Submissions Lead - Global Impact (Hybrid)

CSL; Zürich; Hybrid; CHF 150,000 - 190,000; Full time

Job summary

CSL is seeking a Senior Manager, Regulatory Submission to join its Global Regulatory Submission Management Team. Based in a hybrid setup spanning key markets, you will drive timely, high-quality regulatory submissions across global markets and coordinate with Regulatory, PM, Publishing and external partners to ensure compliance and risk management.

You will oversee external publishing, vendor relationships, and submission planning, while directly contributing to publishing when needed.

Qualifications

• 5+ years of regulatory experience in the pharmaceutical industry.
• Experience with dossier preparation and regulatory submissions across international markets.
• Familiarity with EU, US, Switzerland dossier standards and ICH guidelines.

Responsibilities

• Oversee external publishing and Global Submission Coordinator activities to meet quality, compliance and timelines.
• Manage vendor performance, resources, and continuity while evolving the global vendor model.
• Identify, assess and elevate risks that could affect submission timelines or regulatory outcomes.
• Coordinate and prioritize regulatory submissions across portfolios and support submission planning.
• Oversee preparation, publishing and submission of regulatory packages (eCTD, NEES, paper) for IND/CTA/VARIATIONS and related applications.
• Partner with Regulatory Project Managers to support submission strategy and execution.
• Provide submission planning support, including Excel roadmaps and briefing timelines when needed.
• Ensure submissions meet global standards and timelines; monitor evolving publishing requirements.
• Contribute to continuous improvement of submission processes and standards.

Skills

Regulatory publishing

Vendor management

Cross-functional

Project coordination

Education

Bachelor's degree or higher in Life Sciences/Pharmacy

Tools

Veeva RIM

Job description

CSL is seeking a Senior Manager, Regulatory Submission to join its Global Regulatory Submission Management Team. Based in a hybrid setup spanning key markets, you will drive timely, high-quality regulatory submissions across global markets and coordinate with Regulatory, PM, Publishing and external partners to ensure compliance and risk management.

You will oversee external publishing, vendor relationships, and submission planning, while directly contributing to publishing when needed.