Key Responsibilities

• Regulatory Execution: Act as the primary point of contact for health authorities and lead the hands-on preparation and coordination of meeting requests, responses, and commitments.

• Submissions Management: Coordinate the collection of documents and lead the preparation of submissions for product approvals, including NCEs, post-approval variations, renewals, and import licenses.

• Compliance & Lifecycle: Maintain local processes for labelling and packaging compliance and conduct regulatory impact assessments for manufacturing and artwork changes.

• Pharmacovigilance (PV): Support and ensure pharmacovigilance activities are processed in compliance with local regulations, including handling ICSRs, PSURs, and safety oversight on patient support programs.

• Cross-Functional Collaboration: Partner with Quality, Supply Chain, and Commercial teams to translate regulatory requirements into actionable plans.

Who We Are Looking For

• Education: Bachelor’s degree in Pharmacy, Pharmacology, or Life Sciences (Master’s degree is an advantage) .

• Experience: Minimum 3–5 years of experience in regulatory affairs, product registration, and compliance.

• Technical Knowledge: Practical experience coordinating regulatory submissions and responding to HA questions, with working knowledge of Hong Kong and Macau regulatory pathways.

• Languages: Fluency in both written and spoken English and Chinese (Cantonese +/- Mandarin) .

• Skills: Strong attention to detail, analytical skills, and the ability to work independently in a fast-paced environment.