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Quality / Regulatory Affairs Manager

Location:  Samut Sakhon
Salary: Negotiable

Key Area and Responsibilities:

1.    Manage all activities pertaining to product registration and other regulatory approvals,
      including registration plans and submission strategies, product advertising, product
      reports, and company license renewals
2.    Arrange packaging artworks of registered products and ensures all activities under
      responsibility comply with relevant regulations and company SOPs
3.    Provide regulatory advice and regulatory information to relevant colleagues, and
      manages regulatory matters as assigned
4.    Represent the company position on regulatory affairs-related matter in dealing with the
      regulatory authorities concerned
5.    Liaise with local regulatory authorities, local contract manufacturers, local
      distributor/customers and relevant local staff
6.    Coordination with Q&R team on the deliverables and perform gap analysis,
      preparation/review of document packages or the pre-market regulatory submissions
      locally and if required
7.    Prepares/review and submits Field Corrective Action reports and adverse event reports
      to the local competent authority, ensure the closure is obtain from the competent
      authority, if required, including any additional communications to local competent
      authority.
8.    Good Communication skills, including maintaining good working relationships with local  
      competent authorities and various different departments or agencies.
9.    Support and maintain the local Quality Management System(s) (policies, procedures,
      work instructions), with revisions

Qualifications:
1.    Bachelor’s Degree with at least 5 years of experience in Quality and/or Regulatory   
       Affairs.
2.    Male/ Female age between 35-45 years old
3.    Bachelor’s Degree required preferably in the Food Sciences, Food Technology or other
       related field.
4.    Minimum 5 years working experience in Regulatory Affairs and New innovation   
       products, Novel Foods, Processing Aids, Nutritional Supplement and Food additives or
       other related areas
5.    Proficiency in the use of Microsoft Access and Excel is an advantage.
6.    Strong interpersonal skills in the areas of verbal and written communication, telephone  
       courtesy and professionalism.
7.    Attention to detail and the ability to maintain confidentiality of product registration
       documents.
8.    Ability to prioritize and handle several projects concurrently.
9.    Must be a team player and capable of working with minimal supervision.
10.  Scientific background in regulatory affairs


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