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About the role
Key responsibilities & impact- Oversee external publishing and Global Submission Coordinator activities
- Manage vendor performance, resource allocation, operational standards, and business continuity
- Identify, assess, and escalate risks affecting submission timelines or regulatory outcomes
- Coordinate and prioritize regulatory submissions across portfolios
- Support submission planning activities
- Oversee preparation, publishing, and submission of regulatory packages, including eCTD, NEES, and paper submissions
- Support NDA, BLA, IND, CTA, PSUR, and Variations applications
- Partner with Regulatory Project Managers and cross-functional teams on submission strategy, planning, and execution
- Provide submission planning support using Excel-based roadmaps, storyboards, and briefing book timelines
- Ensure submissions meet technical format requirements, global standards, quality expectations, and timelines
- Monitor evolving regulatory publishing requirements and improve global submission processes and standards
- Provide vendor oversight and directly publish or coordinate submissions when needed
Requirements
What you’ll need- Bachelor’s degree or higher in Life Sciences, Pharmacy, or a related field
- 5+ years of regulatory experience within the pharmaceutical industry
- Preferably 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 the EU, US, Canada, Switzerland, and Australia
- Familiarity with 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
- Strong understanding of regulatory submission processes, publishing requirements, quality standards, and submission timelines
- Strong organizational and communication skills
- Ability to manage multiple priorities and collaborate across functions and geographies
Benefits
Comp & perks- Our Benefits information provided via CSL’s well-being benefits page
- Inclusion and Belonging initiatives
- Reasonable accommodation for applicants with disabilities