STADA (Thailand) Co., Ltd.

Regulatory Affair Manager

STADA (Thailand) Co., Ltd.
Salary provided
Posted on 20 Nov 2020

Regulatory Affair Manager

STADA (Thailand) Co., Ltd.

Job Highlights

  • Focus on the following area of registration
  • Fluent in English communication
  • Review packaging label of finished product before

Job Description

Responsibilities:
  • Focus on the following area of registration
  • Registration submission and Registration approval as per timeline.
  • Advertising submission and Advertising approval as per timeline
  • Regulatory monitoring on any update required by Thai FDA
  • Co-operate with regional and/or global for artwork development to meet delivery timeline.
  • Local BE studies and co-ordination of international BE studies or local clinical trial with third party and expedite the submission to Thai FDA.
  • Reporting Adverse Drug Events in Thailand according to local regulation and corporate policy.
  • Training of staff on ADR and Pharmacovigilance.
  • Co-ordinate cross-functional activities with logistics, marketing and sales.
  • Focus on data quality
  • Review and prepare the registration files.
  • Update the registered files if there are any variations
  • Review artwork of packaging materials e.g. carton, label, leaflets and stickers
  • Review packaging label of finished product before release

Key Qualifications:

  • At least 5 years experiences in Drug regulatory affairs and 2 years experiences on Pharmacovigilance /Drug safety areas
  • Experiences on food supplement and medical device is advantaged.
  • Fluent in English communication
  • Proven ability to collaboration with other functions.
  • Customer focus both internal and external with prompt response.
  • Dynamic, proactive and with high level of self-motivation, with a demonstrated sense of urgency and passion.

Additional Information

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

Company Overview

STADA (Thailand) Co., Ltd is a subsidiary of STADA Group, leading manufacturer of high- quality pharmaceuticals base in Germany with 11,100 employees. With a long-standing heritage rooted in pharmacies, we are perceived as a reliable and trustworthy partner for 125 years.

STADA focuses on a two pillars strategy consisting of generics, including specialty pharmaceuticals and non-prescription consumer healthcare products. Worldwide, we sell its products in approximately 120 countries.

Additional Company Information