Kensington Associates Recruitment (Thailand) Ltd.

REGULATORY AFFAIRS MANAGER

Kensington Associates Recruitment (Thailand) Ltd.
ตำแหน่งงานนี้มีการระบุเงินเดือน
ลงประกาศเมื่อ 01 Mar 2021

REGULATORY AFFAIRS MANAGER

Kensington Associates Recruitment (Thailand) Ltd.

ไฮไลท์เด่นของงาน

  • Degree in Pharmaceutical Sciences
  • 6 years’ experience in Regulatory Affairs
  • medical devices and pharmaceutical industry

รายละเอียดงาน

REGULATORY AFFAIRS MANAGER

  • Responsible for registration of products both under Pharmaceutical product, Medical Devices or others as related to Thai FDA and other government agency.
  • Maintain company’s licenses both import licenses and product licenses
  • Ensure the variation submission and approval for the business continuity.
  • Develops and implements strategies and tactics to expedite registrations, contributing to the earliest possible introduction of products and attainment of corporate objectives.
  • Responsible for all labeling development, promotional material approval and other Regulatory Affairs including the post-marketing requirement.
  • Provide the guidance to relevant associates for the promotional material approval.
  • Provide regulatory support of marketed products.
  • Works with the Industry Association for the new regulations.
  • Ensure the company comply to related act e.g. pharmacovigilance, Safety Monitoring Program.
  • Ensure the company have all mandatory reports.
  • Communicate with Regional and Global to get the right dossiers, prepare and submit registrations dossiers according to updated requirements e.g. ICH, ACTD and CSDT.
  • Present registration dossiers to relevant government agency, discuss scientific issues and enhance/ expedite the progress of approval.
  • Escalate and follow the updated procedures of Regional or Global to get the proper approval of new projects.
  • Work with cross functional associates e.g. Supply chain and Marketing to ensure the goods clearance at the port.
  • Manage all systems for data base to maintain records of all registration activities, artworks  labeling and promotional material approval.
  • Provide the report of new regulations and the business impact .
  • Maintain and create the good relationship with Thai FDA authorities.
  • Prepare the local SOP to align with the company direction.

Qualifications:

  • Degree in Pharmaceutical Sciences or related field and Master degree in management or sciences
  • 6 years’ experience in Regulatory Affairs
  • 8 years’ experience in Regulatory Affairs with at least 3 years’ experience in MNC of medical devices and pharmaceutical industry.
  • Thorough knowledge of regulatory requirements at least for medical devices and pharmaceutical products.
  • Understand the unique requirement of Contact Lens Care.
  • Good government relations especially Thai FDA for both Drug bureau and Medical Devices Control Division
  • Managerial skills , Good communication skill, Interpersonal skill, learning agility

All interested applicants are most welcome by sending the application with attached full resume in English indicating qualifications and experience, current salary, expected salary and recent photo to given.

Please send CV to

Kensington Associates Recruitment (Thailand) Ltd.

Unit 4/1, 4th Floor, Bangkok Union Insurance Bldg 1

75-177 Surawongse Rd, Bangrak, Bangkok 10500

Tel: 02 634 8884-6 Fax: 02 634 8883
Website: www.kensington.co.th 

รายละเอียดเพิ่มเติม

ระดับตำแหน่งงาน
หัวหน้างาน
ระดับการศึกษา
ปริญญาตรี
อายุงาน
5 ปี
ประเภทการจ้างงาน
งานเต็มเวลา, งานประจำ
เว็บไซต์บริษัท

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URGENTLY REQUIRED !!!

Kensington Associates Recruitment (Thailand) Limited.

Kensington Associates was established in 1996 and since inception has positioned itself as a dynamic and successful Executive Search and Selection firm, working hand in hand with clients, providing a consultative talent sourcing solution. With offices in Thailand, China and Hong Kong, Kensington's client portfolio is made up of market leading, multinational and local organizations operating across Industries and functions.

Kensington Associates' clients demand the highest quality candidates. If you count yourself amongst this elite group we at Kensington Associates would like to hear from you. All of our candidate's details are treated with the greatest of confidentiality. No information is released about our candidates without their expressed permission.

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