Manager, Regulatory Affairs
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Your role:
Were hiring an experienced Regulatory Affairs Manager within the Global Regulatory Affairs group based in Melbourne. You will work on all CSL Seqirus manufactured products across the Asia Pacific region which covers influenza vaccines and Products of National Significance (PNS) including snake/spider antivenoms.
Reporting to the APAC/LATAM Regulatory TA Lead Vaccines and as part of a close knit team you will:
- Actively contribute to and support the formulation and implementation of the regional regulatory strategy for CSL Seqirus manufactured products. This will include product development and complex technical changes
- Assist in providing Asia Pacific regional expertise to ensure dossiers and regulatory submissions meet content requirements for applicable territories including negotiating with relevant Health Authorities as required
- Participate in the preparation and submission of high quality applications in CSL Seqirus territories including marketing authorisation applications variations renewals and responses to questions
- Ensure that all regulatory agency correspondence and submissions are managed within the relevant databases and tracked to ensure regulatory compliance
- In collaboration with Global Strategic Labelling assist in the maintenance of up to date product labelling for all relevant CSL Seqirus territories including translation requirements
- Establish and maintain strong and collaborative working relationships with National Health Authorities across the region.
Your experience:
- Tertiary qualification in biological science allied medical discipline or pharmacy
- At least 7 years experience in regulatory affairs in any of the above industries working within the Asia Pacific region
- Prior experience in negotiating with the local Health Authorities and driving regulatory submissions including marketing authorisation applications to approval
- Prior regulatory experience in vaccines is preferred; Prescription Medicine experience is mandatory
- Demonstrable strong positive established relationships with Health Authorities
- Flexibility and a track record of working effectively within a global organisation comprising a range of different functional areas and cultures
- Strong customer focus
- Knowledge of device requirements would be a distinct advantage.
At CSL youll be part of a global purposedriven team dedicated to protecting people and communities from influenza and other serious diseases. Youll 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 February 27th 2026
About CSL Seqirus
CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis 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 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 our On the Front Line video to learn more about CSL Seqirus
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Join the thousands of people who safely donate plasma each week at CSL Plasma and get rewarded for your time.
