Regulatory Affair Executive

Location: Bangkok Province, Thailand
Job Type: Permanent
Salary Negotiable
Specialization: Life Sciences, Healthcare, Medical Devices & Pharmaceutical
Sub Specialization:
Contact: Asama Pannoppa
Reference: JO-1912-432767

Job Description

  • Act as a single point of contact for technical expertise in local laws, regulations, regulatory requirements and other regulatory related guidance in product registration of generic, new generic and new drugs in Thailand
  • Ability to interpret regulations, technical guidelines, policies from the local Health Authority, translate into regulatory strategy, bringing innovative solutions and apply successfully in new MA applications and MA maintenance work
  • Provide regulatory input throughout the product life cycle, anticipate regulatory obstacles, propose strategies, monitor emerging issues and identify solutions and are involved in business/organization activities, management and strategy
  • Negotiate and interact with regulatory authorities during the development and review process to ensure product registration submission and approval
  • Provide guidance and coaching to develop local RA team members
  • Overview of submission compilation up to approval and launch

Qualifications

  • Minimum Bachelor's Degree in Pharmacy / Pharmaceutical Science
  • 2 - 3 years' experience with new generic and new drugs registration in Multi-national companies in Pharmaceuticals
  • Excellent communication in English in both verbal and written
  • Strong knowledge of Thailand regulatory authorities, laws, regulation, generic/new generic/new drug registration requirements and guidelines
  • Good interpersonal skills
  • Good negotiation skills

The successful candidate will be provided a promising career opportunity and attractive compensation package. To submit your application, in strict confidence, please send your full resume in Word format by click "Apply Now"

For a confidential discussion please call 02-106-8685 and ask to speak to K.Asama
Your application will be treated with strict confidential.

en world Recruitment (Thailand) Co., Ltd.
Athenee Tower, 12th Floor, Unit 1201-1202
63 Wireless Road, Lumpini, Pathumwan, Bangkok 10330 Thailand
Tel: +66 (2) 106 8600 | Fax: +66 (0) 2654 0901
www.enworld.com/th/