Connecting...

REGULATORY AFFAIRS MANAGER

Job Title: REGULATORY AFFAIRS MANAGER
Location: Bangkok
Industry:
Salary: Salary provided
Reference: JTH300003001333797
Contact Name: 358DB
Contact Email: 358DB@prtr.com
Job Published: March 16, 2017 17:12

Job Description

Company Background:

Our client is a company that was founded in the USA and is one of the world’s leading providers of health care products and medical devices. The company is currently seeking for a suitably qualified candidate to fill the position of Regulatory Affairs Manager.

Salary:       Negotiable

Location:   Bangkok

Job Description:

  • Driving reduction of registration cycle time through Speed to Market initiatives.
  • Working closely with Global RA team to obtain complete registration documents for faster product registrations in Thailand.
  • Understanding and influencing Thailand regulatory environment by leveraging key relationships with industry groups.
  • Defining and implementing regulatory strategies and plans for 3 Business Units in Thailand.
  • Assisting Commercial team on product artwork and labelling compliance.
  • Supporting Regional QA in the development and implementation of Quality Systems in Thailand.
  • Providing leadership for interpretation; providing support and advice to the parties involved (employees, customers, distributors, suppliers, etc.) to understand and follow the SOPs in accordance with Corporate Quality Policy.
  • Providing training to Thailand employees in all RA & QA related subjects.
  • Managing Pharmacovigilance, product compliance, non-compliant products and processes in collaboration with Global RA, Global QA and commercial teams.
  • Managing people, budget and resources of Regulatory Affairs.
  • Supporting Regional QA to ensure that company and distributor warehouses meet global standards.
  • Focusing on new product registration and paper work.

Qualifications:

  • Male or female, aged at least 30 years old.
  • Bachelor’s degree in Pharmacy.
  • Must be familiar with Regulatory environment and have an understanding of labelling regulations and controls.
  • At least 5 years of experience in regulatory affairs and product registration management.
  • Must be able to interact with internal Client teams and manufacturing site personnel in a professional manner.
  • QA knowledge and experience is an asset.
  • Solid work experience with Multi-National Companies with Pharmaceutical experience.

Qualified candidates please submit your resumes stating present and expected salary & package details via APPLY NOW

Get similar jobs like these by email

By submitting your details you agree to our T&C's