Manager - Pharmaceutical Regulatory Affairs

2 weeks ago

Melbourne, Victoria, 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 uptodate 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

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