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Research & Development Function - Regulatory Affairs Manager - Full Time - HK

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Description

Government Relations

Interfacing with local government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of our products.

Regulatory
  • Product Registration Administration

Submission & Renewal

  1. To liaise with Regulatory Affairs from manufacturing country and HK marketing team in obtaining information for registration submission/ notification

  2. To initiate the registration process per application procedure and obtain timely approval

  3. Responsible to ensure the application and renewal of appropriate licenses required for regulatory compliance are done appropriately, i.e. Import & Wholesale License

Internal Regulatory Approval

  1. Responsible for reviewing and approving appropriate internal documents across categories that pertain to matters such as formulation change, raw material change, etc. and to advise Regulatory Affairs on issues that would breach local regulations and provide solutions

Consumer Complaint
  1. Responsible to assist, follow-up and resolve on any heath or regulation related complaints of company products.In this area to work with Medical Affairs Manager and local Consumer Relations / Public Affairs personnel

  • Advertising
Label Artwork Approval
  1. Internal evaluation of all label artworks prior to printing for all products

Advertisement Material Approval

  1. Internal evaluation of all other advertising materials
  • Success Criteria
  1. Regulatory compliance
  2. Meeting and delivering company’s strategy and plans
  3. Timely approval of product registration


Qualifications
  • Experience
  1. Proven leadership in technical mastery and problem solving skills
  • Knowledge
  1. Professional maturity and ability to operate in a fast paced, competitive and adversarial work environment
  2. Good understanding of local regulations and its set-up
  3. Basic knowledge of global consumer products regulations. At minimum leading countries like USA, EU, Japan
  4. Basic awareness and general knowledge in the scientific areas
  5. Understanding who is the right ally to be the medium and / or to strike partnership with them to champion our business needs (e.g. industry association)
  6. Ability to analyze, articulate and proactively advocate a position for a Company. This requires a capacity to assimilate complex details quickly
  • Skill
  1. Communication
  2. Negotiating
  3. Strategic and analytical thinking
  4. Leadership quality
  5. Highly collaborative working effectively with others
  6. Initiative and follow through
  7. Ability to generate and maintain networking (that matters to the business)
  • Attitude
  1. Passionate ownership
  2. Patience and maintains calm
  3. Integrity and personal courage
  4. Generate respect and credibility
  • Requirements

Mater Degree or above in pharmaceutical sciences, chemistry, human biology, medical sciences, biochemistry or biology. Fluency in English, Mandarin and Cantonese; and good written English and Chinese.

At least 3-5 years of experience in Regulatory affairs (Fast moving consumer goods, drugs/ medical device). Background of MNC. Experience and skills in working with officials from health departments, regulatory bodies and give them influence. Experience to work with R&D departments and marketing team.

Job locations:
Hong Kong SAR
Job Type: Full-time Req No: RND00004061
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