CSL Behring
Manager - Pharmaceutical Regulatory Affairs
This job is now closed
Job Description
- Req#: YCLCGeXTpbmFP2ZXS6wuSA
- 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
- 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 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.
- 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
- Prior experience negotiating with the local Health Authorities and driving regulatory submissions, including marketing authorisation applications, to approval
- 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.
Job Description
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.
Your responsibilities
Your experience
We look forward to receiving your application!
About Us
Our Benefits
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 Seqirus.
About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.
Do work that matters at Seqirus!
About the company
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies. CSL is the parent company of CSL Behring.
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