Regulatory Submission Manager at CSL

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

08 Jun, 26

Salary

0.0

Posted On

10 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Submissions, Submission Preparation, Reporting Tools, Risk Management, eCTD, NEES, Lifecycle Management, Post-Approval Applications, Vendor Oversight, Publishing Standards, Veeva RIM Suite, Organizational Skills, Attention To Detail, Cross-functional Teamwork, Global Regulatory Compliance

Industry

Pharmaceutical Manufacturing

Description

We are seeking a Regulatory Submission Manager to contribute to the delivery of high‑quality, timely global regulatory submissions supporting our investigational and marketed products. In this role, you will play a key part in coordinating regulatory submission activities across multiple regions, partnering closely with cross‑functional teams and external vendors to ensure compliant, efficient, and strategically aligned submission packages. Key Responsibilities: Act as an engaged member of GRAST teams, supporting submission preparation activities. Deliver clear and concise submission status updates through dashboards and reporting tools. Identify, manage, and escalate risks that could affect regulatory timelines or outcomes. Oversee the preparation, publishing, and submission of global regulatory packages, including eCTD, NEES, and paper formats across investigational, marketing, lifecycle, and post‑approval applications. Coordinate submission priorities and planning across business units and product portfolios. Provide oversight of publishing vendors, including performance monitoring, resource support, and adherence to standards. Ensure compliance with global regulatory publishing and submission standards, while monitoring evolving international requirements. About You You will thrive in this role if you bring: A Bachelor’s degree (or higher) in Life Sciences, Pharmacy, or a related discipline. 5+ years of pharmaceutical regulatory experience, ideally within publishing or submission management. Experience preparing dossiers for core and international markets. Working knowledge of health authority requirements across EU, US, Canada, Switzerland, and Australia, as well as ICH guidelines. Familiarity with electronic document management systems such as Veeva RIM Suite. Experience partnering with or managing outsourced publishing vendors. Exceptional attention to detail, strong organisational skills, and the ability to navigate a matrixed global environment. If you’re motivated by meaningful work, global collaboration, and advancing regulatory excellence, we’d love to hear from you. Applications Close on March 22nd 2026 About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement. CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here. CSL Global Privacy Notice for Job Applicants and Candidates

Responsibilities

The manager will coordinate global regulatory submission activities across multiple regions, partnering with cross-functional teams and vendors to ensure compliant and strategically aligned submission packages. Key duties include overseeing preparation, publishing, and submission of global regulatory packages in various formats and monitoring evolving international requirements.