Reeracoen Recruitment Co., Ltd.

Regulatory Affairs Executive (50K-65K) [Job ID: 52462]

Reeracoen Recruitment Co., Ltd.
Salary provided
Posted on 23 Feb 2021

Regulatory Affairs Executive (50K-65K) [Job ID: 52462]

Reeracoen Recruitment Co., Ltd.

Job Highlights

  • Bachelor's degree in any related field
  • Fluent in English skill
  • Work exp. of registering of drug or medical device

Job Description

Salary: 50,000-75,000 THB

Industry: Medical & Healthcare, Manufacturing(Pharmaceutical/Medical Equipment), Trading Firm

Location: Ploenchit Rd., Lumpini, Pathumwan, Bangkok

Work Type: Mon.- Fri. 09.00-17.00

Job description:

  • Liaise with the FDA and regulatory consultant(s) on matters pertaining to regulatory-activities, licenses and permits for new and existing products. Products include drugs, medical devices, food Products and cosmetics.
  • Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new Products based on regulatory expertise with regulations & processes.
  • Review technical dossier of new Products and prepare additional documents where necessary.
  • In-charge with the timely approval and renewal of product licenses, company licenses, pre- and post-approval variations, permits and other applications.- Handle post-marketing activities and yearly reporting requirements of company and product licenses.
  • Review and approve advertising and promotional items to ensure regulatory compliance. And submit to FDA.- Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages.
  • Keep updated with FDA regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
  • Researching and implementing new upcoming GDP regulation. For medical device.

General qualification:

  • Male or Female, Thai national, Age 27~40 years old
  • Fluent English skill to communicate with International R&D Manager(s) and staff In Japan
  • Experienced of registering of new or generic drug
  • Experience of creation of ACTD format for new or generic drug

【Advantage】
  • Experience of drug, medical device and/or cosmetic product classification

【Personality】
  • Flexible person for new jobs
  • With the sense of Team Work.
  • If there is any problem, the person will come to the store and solve it on one's own. Speedy work
  • Logical way of thinking

Benefit package:

  • Social Security Fund
  • Medical Allowance (2000 THB for each)
  • Annual Health Checkup
  • Car Depreciation (approx 5000 THB)
  • Gasoline Allowance (approx 5000THB)
  • BONUS (1-3 months, once per year)
  • Others

Contact (ติดต่อ)

Time: 8.30 am-5.30pm
Office Number: 02-2539800
Website : http://www.reeracoen.co.th
Instagram : reeracoenthailand
Facebook : Reeracoen Recruitment

Additional Information

Career Level
Entry Level
Qualification
Degree
Years of Experience
N/A
Job Type
Full Time, Permanent

Company Overview

As your Partner For Successful Recruitment

Employment is important judgement, influencing the development and growth of the company.

For creating a great encounter between a company and job seeker.

We thank for the encounter with every client who chose us, and support for successful recruitment as their partner. That is our wish.

Additional Company Information