Senior Regulatory Affairs Professional
On-siteVictoria, Central and Western, Hong Kong
Job Summary
Manage and lead various products to ensure compliance with all internal and external regulatory requirements for Australia. Develop regulatory strategies to support business operations and prepare documentation for regulatory dossiers, drug master files, licence renewals, and responses from regulatory bodies. Track progress and due dates for open matters, licensing, and data entry while maintaining a diligent workflow for legal and regulatory functions. Work independently in a fast-paced environment with at least five years of pharmaceutical regulatory experience. Join a global pharmaceutical leader expanding its R&D sites and high-volume manufacturing capabilities in Victoria.
Required Qualifications
- work well under pressure in a fast paced dynamic environment
- Management and leadership of various products ensuring compliance with all internal and external regulatory requirements for Australia
- Managing on-going compliance requirements and develop regulatory strategies to support the business
- Preparing documentation for regulatory dossiers, drug master files, licence renewals and responses to questions from regulatory bodies
- Diligent and organised in your approach to workflow for legal and regulatory functions, including tracking progress and due dates of open matters, licensing and data entry
- work independently
- show resilience to changes
- Degree qualified (Bachelors or higher)
- At least 5+ years pharmaceutical industry experience (in Regulatory Affairs)
- Well versed in regulatory planning, submission preparations and discussions with regulatory bodies
- Proficient with project planning
- Stellar attention to detail
- strong organizational skills
- manage multiple tasks professionally
Desired Qualifications
- eCTD
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