Regulatory Affairs Executive
Hugh Source (International) Ltd
- Company Industries:Trading and Distribution
Job Information
- Post Date:2017-04-10
- Career Level:Entry Level
- Location:Not Specified
- Salary:Salary provided
- Employment Type:Full Time, Permanent
- Job Function:Product Development / Management Others Pharmaceutical
Job Description
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 regulatory guidance 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 and warehouse 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 least 2 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
Remuneration package & fringe benefits including medical scheme will be offered to the right candidate. Please send full resume with availability, current and expected salary by clicking "Apply Now" Attention: Ms Ngai. Please state the job title and reference on the subject heading.
Candidates who are not invited for interview within six months may consider their applications unsuccessful.
All applications will be treated in the strictest confidence. Data collected will be used for recruitment and other employment-related purposes only.
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