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Regulatory Affairs Manager - Thailand at Airswift

Position Regulatory Affairs Manager - Thailand
Posted 21 Apr 2026
Expired 21 May 2026
Company Airswift
Location Australia | AU
Job Type Full Time

Job Description:

Latest job information from Airswift for the position of Regulatory Affairs Manager - Thailand. If the Regulatory Affairs Manager - Thailand vacancy in Australia matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at Airswift for the position of Regulatory Affairs Manager - Thailand below matches your qualifications.

Regulatory Affairs Manager

Reports to: Director, Regulatory Affairs APAC

Dotted line: Project Manager

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

Responsibilities

Regulatory Affairs activities for lifecycle management of pharmaceutical products including but not limited to:

  • Support change applications (Administrative, Labelling, Chemistry Manufacturing & Controls, Safety) including submission strategy
  • Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
  • Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents
  • Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry Manufacturing Controls, Medical Science, publishing team
  • Update/local Product Information (Labelling translation)
  • Check regulatory compliance of product information/artworks
  • Marketing Authorization withdrawal
  • Marketing Authorization Holder transfer
  • Licence renewal
  • Periodic Safety Update Report contribution
  • Invoice check (e.g. Authority invoices)
  • Request Translation/additional Module 1 documents, e.g. Quality Practices declaration, Good Manufacturing Practices
  • Databases maintenance: archiving, tracking
  • Management of local Regulatory Affairs requirements (local regulatory intelligence)
  • National Competent Authorities electronic systems for submission as locally required
  • Contact with the local Health Authority on behalf of the client
  • Cross-functional communication to all relevant departments in relation to regulatory strategy and submission as well as issues related to Lifecycle Management activities
  • Support of Country Regulatory Affairs Head in issue management (e.g. Product Quality Controls Standards Quality, Safety issues like stock out situations management, Dear Healthcare Professional Letter preparation coordination and submission in accordance with local regulations and company Standard Operating Procedures, represent Regulatory Affairs in internal meetings and committees)
  • Review of Promotional Materials
Education
  • You have a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field
Experience
  • Minimum of 5 years’ experience working in regulatory affairs within the pharmaceutical or healthcare industry or in a consulting setting
  • Excellent project management and stakeholder engagement skills
  • Ability to work independently and in a fast-paced consulting environment
  • You thrive on diversity and challenge and can effectively project manage and deliver several projects at once

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Job Info:

  • Company: Airswift
  • Position: Regulatory Affairs Manager - Thailand
  • Work Location: Australia
  • Country: AU

How to Submit an Application:

After reading and understanding the criteria and minimum qualification requirements explained in the job information Regulatory Affairs Manager - Thailand at the office Australia above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.

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