Senior Manager, Regulatory Submission
CSL
Summary
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.
Job description
The Opportunity
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 escalate 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.
Requirements
- 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.
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.