Manager - Pharmaceutical Regulatory Affairs

4 days ago

Melbourne, Australia Seqirus A CSL Company Full time

A permanent, full-time role within our Global Regulatory Affairs group has become available. This role is for an experienced Regulatory professional and includes working on all CSL Seqirus manufactured products across the Asia Pacific region. This includes influenza vaccines and Products of National Significance (PNS) including snake/spider antivenoms.

Remote working can be considered if required given the international scope of this position.

**Responsibilities**:

- Reporting to the APAC Regional Therapeutic Area Lead-Vaccines, you will contribute to the formulation and implementation of the regional regulatory strategy for CSL Seqirus manufactured products. This will include product development and complex technical changes
- Provide Asia Pacific regional expertise to ensure dossiers and regulatory submissions meet content requirements for applicable territories, including negotiating with relevant Health Authorities as required
- 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 help maintain up-to-date product labelling for all relevant CSL Seqirus territories including translation requirements
- Establish and maintain 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; prior experience in vaccines or Asia Pacific markets is preferred
- Established relationships with Health Authorities
- A track record of working within a global organisation comprising a range of different functional areas and cultures
- Knowledge of device requirements would be a distinct advantage.

Our Benefits

CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the

benefits

you can participate in when you join CSL Seqirus.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: 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. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL

Seqirus


We want CSL Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about

Diversity & Inclusion

at CSL Seqirus.

Do work that matters at CSL Seqirus

  • Regulatory Affairs Specialist

    1 week ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Manufacturing Organisation - Regulatory Support for Products within Asia Pacific Markets - Melbourne Metro Area - Hybrid Role - WHF & Site based **About the Company**: Operating as a progressive and highly respected pharmaceutical manufacturing organisation, our client is well known for its operational excellence, passion for...

  • Senior Regulatory Affairs Associate

    3 weeks ago

    Melbourne, Victoria, Australia DBG Health Pty Full time

    OverviewSenior Regulatory Affairs Associate to join our high-performing Regulatory Affairs team.About DBG Health & Arrotex PharmaceuticalsDBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,500 dedicated professionals, we are committed to delivering affordable and innovative solutions...

  • Senior Regulatory Affairs Associate

    3 weeks ago

    Melbourne, Victoria, Australia DBG Health Pty Full time

    OverviewSenior Regulatory Affairs Associate to join our high-performing Regulatory Affairs team.About DBG Health & Arrotex PharmaceuticalsDBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,500 dedicated professionals, we are committed to delivering affordable and innovative solutions...

  • Senior Regulatory Affairs Associate

    3 weeks ago

    Melbourne, Victoria, Australia DBG Health Full time

    OverviewDBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne, with over 1,500 professionals. Arrotex Pharmaceuticals is Australia\'s largest and most diversified pharmaceutical provider. The companies aim to deliver affordable, timely, and innovative solutions that enhance quality of life. Our values are...

  • Senior Regulatory Affairs Associate

    3 weeks ago

    Melbourne, Victoria, Australia DBG Health Full time

    OverviewDBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne, with over 1,500 professionals. Arrotex Pharmaceuticals is Australia\'s largest and most diversified pharmaceutical provider. The companies aim to deliver affordable, timely, and innovative solutions that enhance quality of life. Our values are...

  • Senior Regulatory Affairs Associate

    25 minutes ago

    Melbourne, Victoria, Australia DBG Health Full time $104,000 - $130,878 per year

    About DBG Health & Arrotex PharmaceuticalsDBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 1,500 dedicated professionals, we are committed to delivering affordable and innovative solutions that enhance the wellbeing of all people. Arrotex Pharmaceuticals is Australia's largest and most...

  • Product Support and Regulatory Affairs

    2 days ago

    Melbourne, Australia KE Select Full time

    Product support. - Regulatory Affairs - Chemicals **The Company** This company has been a leading distributor in the medical, pharmaceutical, and scientific industries for the last 20 years. They are proud to be delivering high quality technology to the Life Science community in ANZ. **About the role** This is an new opportunity located in VIC. As the...

  • Regulatory Affairs Manager

    1 week ago

    Melbourne Eastern Suburbs, Australia HAYS Full time

    Regulatory Affairs Manager for global medical device company based in Melbourne. **Your new company** This is a global medical device/diagnostic company based in Melbourne looking for a Regulatory Affairs Manager to join there team and support global registrations. **Your new role** Your new role will be managing a team of regulatory professional and...

  • Associate, Regulatory Affairs

    4 weeks ago

    Melbourne, Victoria, Australia Equity Trustees Full time

    Overview Join to apply for the Associate, Regulatory Affairs role at Equity Trustees Join our Corporate and Superannuation Trustee Services (CSTS) business as part of the Legal, Regulatory & Governance Advisory team. This is a dynamic and collaborative role that contributes to our regulatory affairs program, helping us maintain a strong compliance and...

  • Associate, Regulatory Affairs

    4 weeks ago

    Melbourne, Victoria, Australia Equity Trustees Full time

    OverviewJoin to apply for the Associate, Regulatory Affairs role at Equity TrusteesJoin our Corporate and Superannuation Trustee Services (CSTS) business as part of the Legal, Regulatory & Governance Advisory team. This is a dynamic and collaborative role that contributes to our regulatory affairs program, helping us maintain a strong compliance and...