Regulatory Affairs Associate

Job ID : J-00013
Job Location : Bangkok
Posted On : 10/07/2018

Regulatory Affairs Associate  

Key Responsibilities:-

• Responsible for principal management in Regulatory issues including product vigilance systems in Thailand.

• Ensures timely and correct submission and approval of new Marketing Authorization applications in close cooperation with

   local regulatory authorities.

• Ensures maintenance of authorized products through timely submission of variations, renewal applications, and supplemental

   marketing authorizations.

• Acts business oriented in terms of Regulatory Affairs advice to stakeholders during product development, as well as to get         the best authorized product profile, and to register the product for marketing in the shortest period.

• Develop and maintain positive relationship with local regulatory authorities.

• Works alongside the BD, locally, regionally and globally, to support business initiatives in Thailand.

• Determine the types of regulatory submissions or internal documentation that are required in situations according to local

   regulation.

• Maintains a positive relationship with internal and external regulatory contacts.

• Self-sets up priorities, organizes, oversees and monitors activities, towards department's and country's objectives

   achievement  in compliance with policies and standards.

• Through attendance to courses/workshops ensures that they are appropriated updated on new legislations, requirements on

   Regulatory.

• Support RA manager in the Regulatory related activities as assigned.

 

Qualifications:-

  • Bachelor’s  Degree  of   Sciences  in  Nutrition / Food / Pharmacy or related field
  • Minimum 1 year in regulatory affairs or relevant function
  • Understand of regulatory affairs in Food or Nutrition/ Cosmetics/ medical devices /pharmaceutical environment will be an advantage
  • Experience in regulatory affairs, QMS, compliance and/or clinical investigations knowledge of regulations applicable to the business
  • Experience gained in multinational healthcare products /pharmaceutical companies will be an advantage
  • Excellent understanding of the relationship of commercial opportunities to regulatory/compliance
  • High level of responsiveness to need of commercial organization
  • Good judgment, ability to prioritize and resource regulatory activity according to business needs
  • Ability to work in international environment and willingness to travel
  • Good interpersonal, strategically thinking and effective communication skills
  • Analytical, attention to detail and problem-solving skills
  • Good command in spoken and written of English
  • Must be computer literate (MS Office, MS Outlook, Power Point)

PHC is looking for a great confident candidate who has a passion to win to join our team. We offer a competitive remuneration package for the right candidate. If you are interested in this position, please register (top right of  this page) to receive the password and sign in (top right of this page) for online application.

 

  Pacific Healthcare (Thailand) Co., Ltd.,

Human Resources Department

1011 Supalai Grand Tower, Room No.01, 29 th Fl., Rama 3 Rd., Chongnonsee , Yannawa , Bangkok  10120

E-mail: recruit@phc.co.th

Website: www.phc.co.th

Only successful applications will be contacted.



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