Regulatory Submission Manager

CSL

1d•Hybrid

About The Position

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.

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.

Nice To Haves

Previous people leadership experience is a plus.

Responsibilities

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.