Regulatory Submission Manager

Melbourne - Australia

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

We are seeking a Regulatory Submission Manager to contribute to the delivery of highquality 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 crossfunctional 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 postapproval 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 Bachelors 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 youre motivated by meaningful work global collaboration and advancing regulatory excellence wed 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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at 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 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 Experience:

Manager

We are seeking a Regulatory Submission Manager to contribute to the delivery of highquality 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 partner...