Ensure the company pharmaceutical and medical device products meet all regulatory requirements across multiple jurisdictions
Participate in new product development projects and provide regulatory advice at the product initiation stage.
Assess compliance of formulations, ingredients, dosages, and product claims
Provide regulatory guidance for Hong Kong, Macau, and Mainland China markets
Review product packaging, labeling, and instruction leaflets
Collaborate closely with marketing, branding, and design teams
Manage product registration, filing, and related technical documentation
Maintain product dossiers and supplier compliance documents, including COA, GMP, ISO certifications, stability data, safety data, and clinical study documents
Liaise with suppliers, testing laboratories, and government authorities
Requirements:
Bachelor's Degree or above in Pharmacy, Pharmaceutical Science, Life Science, Food Science or related disciplines
Minimum 5 years relevant experience in Regulatory Affairs, Product Compliance or Quality Systems
Strong understanding of Hong Kong health supplement regulations
Familiar with Undesirable Medical Advertisements Ordinance (Cap. 231), Trade Descriptions Ordinance (Cap. 362), Public Health and Municipal Services Ordinance, Chinese Medicine Ordinance (advantage)
