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Regulatory Affairs Manager / Technical External Relations [Background in Food Supplement]


Job Descriptions:

Regulatory Affairs Manager or Technical External Relations supports Regulatory Affairs Team, as assigned,

(1) to manage all activities pertaining to product registration and other regulatory approvals,

(2) to initiate the registration plans and submission strategies, product advertising, drug reports, and company license renewals.

(3) to arrange and review packaging artworks of registered products and ensures all activities (Marketing & Sales Kits/communication tool) under responsibility comply with relevant regulations and company SOPs.

(4) to provide regulatory advice and regulatory information and update new regulatory implications to relevant colleagues and manages regulatory matters.

(5) to represent the company position on regulatory affairs-related matter in dealing with the regulatory authorities concerned.

(6) to build and own decent working relationships with key concerned stakeholders including local regulatory authorities, relevant above-country functions, manufacturing sites, local contract manufacturers, local distributor, local customers, and relevant local staff – Medical, Marketing, Sales, Logistics, Legal and Business Technology.

Job Deliverables:

  1. Product Registration (Food Supplement, Cosmetics, Medical device, Others)
  2. Regulatory and Profession Support/ Advice
  3. Standard Operating Procedures
  4. Functional Administration
  5. Company’s Regulatory Compliance
  6. External Networking
  7. Regulatory Affairs Reports

Qualifications:

  • Bachelor’s degree of Science or Pharmacy
  • At least 7 years of experience in Beauty / Supplement / Food & Beverage industry
  • Excellent relationship with Thai FDA
  • Good command of both Thai and English

Key Competencies:

  • Good problem-solving capability, and ability to work independently and as a team.
  • Strong leadership and good communication skill.
  • Dynamic, proactive and with high level of self-motivation, with a demonstrated sense of urgency and passion.
  • Customer focus both internal and external with prompt response.
  • Eager to learn new things and have an entrepreneurial mindset.- Have an experience in initiating new ideas of Product launch will be a plus
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