Associate, Regulatory Affairs

ExcelNet Total Solutions; Hong Kong; On-site; HKD 240,000 - 360,000; Full time

Job summary

ExcelNet Total Solutions is seeking a Regulatory Affairs Associate to provide regulatory and product safety support to their Regulatory Affairs Department in Hong Kong. The role involves dossier submission, license maintenance, and liaison with authorities.

You will support artwork, advertising compliance, Macau importation, and cross-border business, working with regional teams. Candidates with 1+ year in regulatory affairs in FMCG/pharma/medical devices and bilingual English/Chinese are

Qualifications

• University graduate in biological sciences or pharmacology preferred.
• Minimum 1 year experience in regulatory affairs at FMCG, Pharmaceutical, or medical device background preferred.
• Strong analytical, organizational, and communication skills.
• Detail-oriented, independent, and able to thrive under pressure.
• English and Chinese (Cantonese & Mandarin) proficiency.

Responsibilities

• Compile and submit national dossiers to authorities for product registration and variations.
• Maintain and update product licenses, regulatory compliance files and databases.
• Liaise with government authorities to secure timely approvals with optimal claims.
• Support local artwork creation, advertising and promotional activities to ensure compliance.
• Provide documentation for Macau importation and cross border business.
• Collaborate with regional/global RAS, R&D and Medical Affairs.
• Respond to product queries from internal and external stakeholders.

Skills

Regulatory affairs

Documentation

Communication

Bilingual EN/CN

Education

Bachelor's in Biological sciences or Pharmacology

Job description

Our client is the leading fast moving consumer propducts at healthcare services. We are seeking a Regulatory Affairs Associate to provide regulatory and product safety support to their Regulatory Affairs Department.

Key responsibilities

• Compile and submit national dossiers to authorities for product registration and variations
• Maintain and update product licenses, regulatory compliance files and databases
• Liaise with government authorities to secure timely approvals with optimal claims
• Support local artwork creation, advertising and promotional activities to ensure compliance
• Provide documentation for Macau importation and cross border business
• Collaborate with regional / global RAS, R&D and Medical Affairs
• Respond to product queries from internal and external stakeholders

Job Requirements

• University graduate in biological sciences or pharmacology preferred
• Minimum 1 year experience in regulatory affairs at FMCG, Pharmaceutical, or medical device background preferred
• Strong analytical, organizational, and communication skills
• Detail-oreinted, independent, and able to thrive under pressure
• Commercial awareness, openness to change and team player
• Good command of spoken and written English and Chinese (Cantonese & Mandarin)