Manager in Regulatory Affairs for APAC focusing on data integrity and compliance. Leading regional regulatory teams and improving processes in the pharmaceutical industry.
About the role
- Assistant Manager, Regulatory & Pharmacovigilance in Hong Kong focused on managing regulatory submissions and ensuring compliance. Collaborating with cross-functional teams to maintain product lifecycles and oversee pharmacovigilance activities.
Responsibilities
- Act as the primary point of contact for health authorities and lead the preparation and coordination of meeting requests
- Coordinate the collection of documents and lead the preparation of submissions for product approvals
- Maintain local processes for labelling and packaging compliance
- Support pharmacovigilance activities in compliance with local regulations
- Partner with Quality, Supply Chain, and Commercial teams to translate regulatory requirements into actionable plans
Requirements
- Bachelor’s degree in Pharmacy, Pharmacology, or Life Sciences (Master’s degree is an advantage)
- Minimum 3–5 years of experience in regulatory affairs, product registration, and compliance
- Practical experience coordinating regulatory submissions and responding to HA questions
- Working knowledge of Hong Kong and Macau regulatory pathways
- Fluency in both written and spoken English and Chinese (Cantonese +/- Mandarin)
- Strong attention to detail, analytical skills, and the ability to work independently in a fast-paced environment
Benefits
- inclusive recruitment process
- equality of opportunity for all applicants
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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