
Senior Regulatory Specialist
1 week ago
We are seeking an experienced Regulatory professional to join our Global Regulatory Affairs group. This role includes working on all manufactured products across the Asia Pacific region.
This includes influenza vaccines and Products of National Significance (PNS) including snake/spider antivenoms.
Key Responsibilities:- Contribute to the formulation and implementation of the regional regulatory strategy for manufactured products.
- Provide Asia Pacific regional expertise to ensure dossiers and regulatory submissions meet content requirements for applicable territories.
- Ensure that all regulatory agency correspondence and submissions are managed within relevant databases and tracked to ensure regulatory compliance.
- In collaboration with Global Strategic Labelling maintain up-to-date product labelling for all relevant territories including translation requirements.
- Establish and maintain collaborative working relationships with National Health Authorities across the region.
Requirements:
- Tertiary qualification in biological science, allied medical discipline or pharmacy is required.
- At least 7 years' experience in regulatory affairs, prior experience in vaccines or Asia Pacific markets is preferred.
- Established relationships with Health Authorities and knowledge of device requirements would be advantageous.
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