Manager, Regulatory Affairs

We’re hiring an experienced Regulatory Affairs Manager to join Global Regulatory Affairs in Melbourne, working across CSL Seqirus manufactured products in Asia Pacific, including influenza vaccines and Products of National Significance (PNS) such as snake/spider antivenoms.

This role offers regional regulatory strategy ownership, meaningful Health Authority engagement, and exposure to both high‑volume and high‑criticality products.

Reporting to the APAC/LATAM Regulatory TA Lead Vaccines and as part of a close knit team, you will:

• Drive and implement APAC regulatory strategy for CSL Seqirus manufactured products, including development activities and complex technical/lifecycle changes
• Lead regional regulatory input to dossiers and submissions, including direct interaction and negotiation with Health Authorities
• Prepare and manage high‑quality submissions (MAAs, variations, renewals, HA questions) across CSL Seqirus territories
• Partner cross‑functionally to anticipate and manage regulatory risks and priorities
• Ensure regulatory compliance and traceability via appropriate management of submissions and agency correspondence
• Provide leadership for regional labelling strategy and execution, driving consistent, high‑quality and compliant outcomes across CSL Seqirus territories
• Build and maintain strong Health Authority relationships across the region 

Your experience:

• Tertiary qualification in biological science, allied medical discipline or pharmacy
• 7+ years’ regulatory affairs experience, including Asia Pacific submissions
• Prior experience in negotiating with the local Health Authorities, preparing, filing and driving regulatory submissions, including marketing authorisation applications, to approval
• Prescription Medicine (PoM) regulatory experience (vaccines preferred)
• Strong stakeholder management skills and ability to operate in a global matrix environment comprising a range of different functional areas and cultures
• Knowledge of device requirements would be a distinct advantage.

At CSL, you’ll be part of a global, purpose‑driven team dedicated to protecting people and communities from influenza and other serious diseases. You’ll join a collaborative, dynamic environment where innovation, learning and our values guide everything we do. With strong support for career growth, wellbeing and flexible work, we offer Promising Futures for people who want to make a real impact.

Applications Close on May 24, 2026

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus