Responsibilities:
Regulatory affairs activities of pharmaceutical products, dietary supplements, functional foods and drinks as well as functional ingredients in Hong Kong and worldwide countries including:

Preparation, compilation and submission of dossier to Department of Health

Key liaison person for the Department of Health, oversea distributors and suppliers

Revision of product labelling, product inserts and promotional marketing materials

Provision of updated regulatoryguidance to marketing, product development and logistic teams

Assist in plant audit preparation, translation of clinical papers, SOPs and dossiers, website contents

Assist in ISOs, GMP, Kosher, Halal and other international quality audits and monitoring

Assist in Good Distribution Practice andwarehouse monitory

Assist in patent, trademark application

Assist in clinical studies monitoring

Ad-hoc duties maybe be assigned

Less experienced candidate will be offered Regulatory Affairs Associate

Special requirements:
Degree in Science Related discipline, major in Pharmacy, or Pharmaceutical Science is preferable

At least2 years regulatory experience of pharmaceutical and/or nutritional supplements is definite advantage

Personal attributes:
Meticulous, flexibility, ability to work under pressure

Independent, good time management and good team player

Proficiency in spoken and written English and Chinese

Computer proficiency (Excel, Word, PowerPoint)

Immediate availability is highly preferred

Benefits

Five-day work

Bank Holidays

Performance bonus

Medical Insurance

10+ Days Annual leave

Birthday leave

Paid Marriage Leave

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Full-time