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  3. Regulatory Affairs Executive

Regulatory Affairs Executive

50000 〜 60000 THB

  • RGF HR Agent
  • Location: Bangkok
  • Japanese level:None(+Studying) │Required length of experience:Uncategorized
  • Close
Date:2019/08/15~2020/02/22

Job summary

Job category Administrative (Human Resources / Finance / Legal / Public Relations)/Legal Affairs / Intellectual Property / Credit Management / Compliance
Industry Other/
Employment type Uncategorized
Position level Other
Number of openings 1
Desired entry time -
Required language skill

English (Business)

Foreign language competence -
Working hours Others
Welfares / Leave systems

Work details

Regulatory Affairs Executive (50K-60K) (SDG-36324)
<Job Responsibilities>
 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
 Visit FDA Office 1 -2 times per week



<Necessary Skill / Experience >
 Thai nationality, Male/Female, age 25-35 years old
 Bachelor’s Degree in any field
 Experience as a Register of drug or medical devices
 At least 2-3 years of Experience for Drug RS
 English : Business Level (Able to communicate with Japan HQ)
 Have a logical thinking and problem-solving skills
 Proficient in Microsoft Office
 Solve problem own self
 Team work
 Able to go Business Trip (once or twice a year)

<Preferable Skill / Experience>
 Experience of creation of ACTD format for new or generic drug
 Experience of drug, medical device and/or cosmetic product classification
Languages skills
English: Business Level
Japanese: None

Workplace Area BTS Chitlom, Bangkok
Working Hour: 9:00-17:00 (Mon-Fri)

About the Benefits
Salary: 50,000–60,000THB

About the company
Products: OTC, Pharmaceutical, Healthcare products.
Business Type: Pharmaceuticals

About interview

Liaison

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Name of person in charge of hiring:

Regulatory Affairs Executive

RGF HR Agent

50000 〜 60000 THB

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Company overview

RGF HR AgentRegulatory Affairs Executive RGF HR AgentRegulatory Affairs Executive

RGF HR Agent

Human Resources / Education / Consulting / Professional Services /Staffing / Recruiting

RGF (Recruit Global Family) is the overseas corporation of Recruit Holdings Co., Ltd., Japan's largest talent comprehensive service and information service group enterprise, has started for more than 50 years, based on excellent business philosophy and management experience. Transcend national borders, we will discover new opportunities and possibilities worldwide.
RGF HR Agent provides solid support for the hiring activities of companies and the job-hunting activities of applicants as a general HR service company.
We provide not only regular recruitment but also RPO (Recruitment Process Outsourcing), contracts and so on. We deliver comprehensive services that could only be offered by RECRUIT=RGF, which is number one in Japan in the field of talent introduction, temporary staffing and recruitment information advertising. Having thoroughly met the needs of leading companies in Japan, we will also provide our consummate, high-quality services overseas. RECRUIT=RGF, which is number one in Japan, will continue taking on the challenge of becoming number one in the world.

JAPAN: RGF HR Agent Japan (CDS)
Address: 東京都渋谷区広尾1-13-7恵比寿イーストビル2F
TEL (+81)3-6422-4400
Website: http://www.rgf-hragent.asia/en/japan

CHINA: RGF HR Agent (Shanghai)
Address: 上海市淮海中路8号 蘭生大厦9F
TEL (+86) 21 5331 8000
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Suzhou)
Address: 蘇州市工業園区蘇州大道西1号 世紀金融大厦1615室
TEL (+86) 512 6262 3595
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Beijing)
Address: 北京市朝陽区東三環中路39号建外SOHO,A座902室
TEL (+86) 10 5869 0121
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Tianjin)
Address: 天津市和平区南京路189号津汇広場一号楼1106单元
TEL (+86) 22 2331 1169
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Dalian)
Address: 大连市高新技术产业园区黄浦路537号(七贤路)泰德大厦811室
TEL (+86) 411 8445 7095
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Guangzhou)
Address: 广州市天河区林和西路161号 中泰国际广场A塔1309室
TEL (+86) 20 8527 4585
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Shenzhen)
Address: 深圳市罗湖区嘉宾路2018号深华商业大厦2507室
TEL (+86) 755 8237 5208
Website: http://www.rgf-hragent.asia/china

HONGKONG: RGF HR Agent Hong Kong Limited
Address: Unit 2206, 22/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong
TEL (+852) 2537 2557
Website: http://www.rgf-hragent.asia/en/hongkong

VIETNAM: RGF HR Agent Vietnam Co., Ltd.
Address: RM903 Central Plaza 17 Le Duan St., Dist 1 Ho Chi Minh City
TEL (+84) 8 3911 5800
Website: http://www.rgf-hragent.asia/en/vietnam

THAILAND: RGF HR Agent Recruitment (Thailand) Co., Ltd.
Address: 689 BHIRAJ TOWER at EmQuartier, 23rd Floor, Room No. 2304-2306 Sukhumvit Road, North Klongton Sub-District, Vadhana District, Bangkok 10110
TEL (+66)2-021-0333
Website: http://www.rgf-hragent.asia/thailand/

SINGAPORE: RGF HR Agent Singapore Pte. Ltd.
Address: 71 Robinson Road #05-04 Singapore 068895
TEL (+65) 6221 7437
Website: http://www.rgf-hr.com.sg/

INDIA: RGF Select India Private Limited
Address: 704-705-706, 7th Floor, Vatika City Point, MGRoad, Gurgaon 122002
TEL (+91)124 4139711
Website: http://www.rgf-hragent.asia/en/india

INDONESIA: PT. RGF Human Resources Agent Indonesia
Address: Jakarta Office: Graha Pratama, P1F (21F), Jl. M.T.Haryono Kav. 15, Jakarta 12810, Indonesia
TEL (+62) 21 8378 2866
Website: http://www.rgf-hragent.asia/en/indonesia

Company profile

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