Senior Regulatory Submission Manager

CSL

4

(1)

Australia

Why you should apply for a job to CSL:

  • 4/5 in overall job satisfaction
  • Ratings are based on anonymous reviews by Fairygodboss members.

    #R-271939

    Position summary

    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 15 April 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://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://https://www.csl.com/accessibility-statement.

    Why you should apply for a job to CSL:

  • 4/5 in overall job satisfaction
  • Ratings are based on anonymous reviews by Fairygodboss members.