RGF HR Agent Recruitment (Thailand) Co., Ltd.

Regulatory Affairs (50K–100K) (SDG-58496)/กิจการกำกับดูแล

RGF HR Agent Recruitment (Thailand) Co., Ltd.
เงินเดือนสามารถต่อรองได้
ลงประกาศเมื่อ 22 Feb 2021

Regulatory Affairs (50K–100K) (SDG-58496)/กิจการกำกับดูแล

RGF HR Agent Recruitment (Thailand) Co., Ltd.

ไฮไลท์เด่นของงาน

  • 3 years of Working experience regulatory affairs
  • Business Level (Able to communicate with Japan HQ)
  • Have a logical thinking and problem-solving skills

รายละเอียดงาน

<Job Responsibilities>

  • Liaise with the FDA and regulatory consultant(s) on matters pertaining to regulatory activities, licenses and permits for new and existing products.
  • 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 medicine
  • Visit FDA Office 1 -2 times per week
  • Might be required for oversea trip, such as to Japan. (once or twice a year after Covit19)
  • Other duties assigned

<Necessary Skill / Experience >

  • Thai nationality, Male, Female 25-40 years old
  • Bachelor’s degree
  • At least 3 years of Working experience as regulatory affairs for drug or medicine
  • English : Business Level (Able to communicate with Japan HQ)
  • Have a logical thinking and problem-solving skills
  • Proficient in Microsoft Office
  • Able to go Business Trip (once or twice a year)
  • 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

<Preferable Skill / Experience>     

  • Experience of creation of ACTD format for new or generic drug

Languages skills

English:Business Level

Japanese: None

Workplace Area: BTS Chitlom,Bangkok

Working Hour: 9:00-17:00(Monday to Friday(Sat:none))

About the Benefits
Salary: 50,000–100,000THB

About the company
Products: OTC, Pharmaceutical, Healthcare products 

Business Type:  Pharmaceuticals

3 summary points             

  • Stable and growing company
  • Be responsible for regulatory affairs by cooperating with HQ
  • 3 yeas of Regulatory affairs experience for medicine and drug

HOW TO APPLY,                              

*** Please submit your resume with recent photo, your current & expected salary, and reference: Regulatory Affairs (50K–100K) (SDG-58496)

*** Any query regarding this Job or application method, please call Tel. 02-021-0333

RGF HR Agent Recruitment (Thailand) Co., Ltd.
(株式会社リクルートホールディングスタイ法人)

689 BHIRAJ TOWER at EmQuartier, 23rd Floor, Room No. 2304-2306
Sukhumvit Road, North Klongton Sub-District, Vadhana District, Bangkok 1011
Tel: 02-021-0333

Website : www.rgf-hragent.asia/en/thailand

รายละเอียดเพิ่มเติม

ระดับตำแหน่งงาน
ระดับเจ้าหน้าที่
ระดับการศึกษา
ปริญญาตรี
อายุงาน
3 ปี
ประเภทการจ้างงาน
งานเต็มเวลา, งานประจำ
เว็บไซต์บริษัท

ข้อมูลบริษัท

OPPORTUNITIES FOR LIFE

http://www.rgf-hragent.asia/en/thailand

RGF stands for RECRUIT GLOBAL FAMILY, a global brand of Japan's largest recruiting and information service company, Recruit Holdings Co., Ltd.

They created this brand out of our commitment to take on a new challenge to leverage on Recruit Group's more over 50 years of industry experience and business network in Japan, to provide new opportunities to their clients across the region.

RGF HR AGENT takes charge of RGF's business entity in general recruitment services. We provide total human resource services to clients at every stage of staff placement. At the same time, we assist job-seekers in various ways to find the right job according to their individual preferences and experiences.

Their company's status as the Japan's #1 market share holder in human resource, temporary staffing, and job advertisement field makes it possible for them to provide high quality total human resource management services not only in Japan but across the region. RECRUIT = RGF will continue to take up the challenge to be the #1 recruitment agency in Asia, beyond national boundaries.