In-Demand Director of regulatory affairs Jobs in Victoria

Director Regulatory Affairs ANZ
CSL Behring —Melbourne VIC
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
5d
Senior Manager, Government Affairs
Swisse Wellness —Victoria
- Full-time
- Hybrid work
SENIOR DIRECTOR, COMMUNICATIONS, MARKETING, MEMBER & STAKEHOLDER ENGAGEMENT
SHK Asia Pacific —Melbourne VIC
- CRM software
- Marketing
Clinical Specialist - TAVR - AU
Anteris Technologies —Melbourne VIC
- $145,000 - $200,000 a year
- Remote
- Nursing
- Anatomy knowledge
- Bachelor's degree
- Annual leave
Quick Apply
MS&T Fill & Finish Value Stream Lead
CSL Behring —Broadmeadows VIC
- Full-time
- Engineering
- Master's degree
- Bachelor's degree
8d
Head of Policy | Tax & Legal
Deloitte —Melbourne VIC
- Communication skills
- Parental leave
4d

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Director Regulatory Affairs ANZ

CSL Behring -
Melbourne VIC

Apply Now

Job Details

Full-time
5 days ago

Benefits

Group activities

Qualifications

Doctoral degree
Master's degree
Bachelor's degree
Leadership

Full Job Description

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Global & Regional Regulatory Affairs

Job Type: Full Time

Location: Melbourne, Victoria, Australia

Employer Reference: R-288444

Job Description

CSL is a global leader in biotechnology, dedicated to advancing and protecting public health. We are seeking an experienced Director Regulatory Affairs Australia and New Zealand (ANZ) to play a critical leadership role within Global Regulatory Affairs & Safety (GRAS) APAC Affiliate Cluster. This is a high‑impact position responsible for guiding national regulatory operations, shaping local strategy, and representing CSL in key interactions with Health Authorities and industry bodies.

Your Responsibilities

Reporting to the RA/ PV Cluster Head APAC, GRAS and based at CSL Melbourne headquarters, key responsibilities in this critical role include:

Collaborate with colleagues in Therapeutic Area teams on regulatory strategy decision‑making, ensure regulatory operations, and act as the first point of escalation for challenges.
Provide expert local insights to develop and execute regulatory strategies for new product registrations and lifecycle management, monitoring and communicating progress to stakeholders.
Ensure compliance with ANZ regulatory requirements, contribute to local policy and industry group activities, and support audit/inspection readiness and CAPA completion.
Stay informed on evolving national regulations and guidelines, represent CSL in relevant meetings and forums, and share insights and best practices across the organisation.
Serve as the primary interface with Health Authorities, government bodies, industry associations, and local commercial teams, leading in‑country regulatory processes and market access‑related interactions
Prepare and coordinate local regulatory documentation (e.g., Module 1 and briefing materials), maintain required national systems, support regional teams, and monitor local Health Authority activities.
Ensure compliant labelling, timely updates, promotional material review, accurate records, and adherence to compliance KPIs

Your Skills:

To be successful in this role you will bring:

Bachelor’s degree in a relevant scientific discipline (e.g., biology, chemistry) with advanced degrees (Master’s or PhD) preferred.
Regional regulatory certifications (RAC, CARP, CHPC) are desirable.
10+ years of regulatory experience with significant Health Authority facing responsibilities.
Strong leadership background with experience guiding regulatory teams.
Expertise in Australian and New Zealand regulatory frameworks and external engagement.
Proven ability to manage regulatory submissions, cross‑functional initiatives, and complex timelines.

If you are a seasoned regulatory leader with deep Australian regulatory expertise and a passion for meaningful impact, we invite you to apply and help shape CSL’s future.

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.

Apply Now

Refine Your Search

director of regulatory affairs jobs in victoria

Director Regulatory Affairs ANZ

Senior Manager, Government Affairs

SENIOR DIRECTOR, COMMUNICATIONS, MARKETING, MEMBER & STAKEHOLDER ENGAGEMENT

Clinical Specialist - TAVR - AU

MS&T Fill & Finish Value Stream Lead

Head of Policy | Tax & Legal

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Equal Opportunity Employer

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