Regulatory Affairs Manager

Our client is one of the leading healthcare services companies in Thailand and in Asia. This position is an integral member of the Regulatory Affairs and Quality Assurance Team.

 

Reports to:

  • Senior Regulatory Affairs Manager

 

Purpose of position:

  • Provide support and expertise in area of healthcare product registration to Business Development team in obtaining new business opportunity for regulatory service.

  • Prepare registration application, submit the application and obtain Thai FDA approval for drugs, medical devices, cosmetics, and foods.

  • Ensure returned goods before resold/destroy as GSDP requirement.

 

Responsibilities:

  • Mange all activities related to Regulatory Affairs (pre-submission, submission, and life cycle maintenance).

  • Ensure compliance of regulatory requirements, company & principal policies.

  • Handle the whole process of registration project for Drug products, Medical devices and Foods under FDA requirements and committed timeline.

  • Classify the product to be complied with particular FDA’s channels.

  • Plan, coordinate and manage for lot release to be ready for sale on time.

  • Prepare Certificate to Analysis translation for responsible products.

  • Response to questions and/or comments from FDA authorities.

  • Consults, review, and advise on promotional materials to be published under marketing and sales activities such as, advertising, leaflets, sales promotion programs and all activities related to Regulatory Affairs.

  • Support the team to ensure objective’s meet.

  • Ensure all regulator information and guideline are up to date.

  • Review new statement, circulate to concerned parties.

  • Review all customer questionnaires/queries and ensure all answers meet company’s policy and regulations within committed timeline.

  • Management of Pharmacovigilance activities for responsible products carried out within Thailand according to principal and FDA regulations.

  • Update regulatory submission tracking record and prepare monthly registration status reports for responsible products.

  • Providing support and expertise in area of healthcare product registration to internal steak holder and principals as requested.

 

Key result area (KRA):

  • Pro registration complete as per agreed timeline.

Customer satisfaction in RA services.

Qualifications:

  • Bachelor’s degrees in Pharmacy.

  • Minimum 7 years experiences in area of Regulatory Affairs for healthcare product.

  • Have knowledge on FDA rules and regulation.

  • Have knowledge on Pharmaceutical product license requirement.

  • Good command of Thai and English in writing, listening and speaking.

  • Good computer skill in Microsoft Word, Excel and PowerPoint.

  • Sense of urgency, ability to manage priorities under pressure and be able to multi-tasks.

  • Well-organized, self-driven with good communication, problem solving, hard-working, and reliable.

  • Proactive, assertive, and able to work independently and as team.

If you would like to apply for this position, please send your resume to consultants@utcthailand.com or fill in your information on the section below.

*All applications will be treated in strict confidentiality. All material submitted in connection with your application will become part of our confidential recruitment files. We regret that only shortlisted candidates will be notified.

Job Application

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