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Regulatory Affair Manager (Labelling)

  • Location: Thailand
  • Salary: Negotiable per annum
  • Job Type:Permanent

Posted 3 months ago

  • Sector: Sales & Marketing
  • Contact: Natrawin Suwancharat
  • Expiry Date: 19 April 2023
  • Job Ref: JN -032023-477982

We are looking for Regulatory Affair Manager (Labelling) x 1 Vacancy who taking care of labelling process and report to Global Labelling Manager.

The salary is up-to 150K + benefits

Key responsibilities for this role include:

  • Point of Contact to Global Labelling Team regarding countries/licenses under her/his responsibility
  • Reports on agreed key performance indicators for set region.
  • Onboards and manages regional assigned labelling associates.
  • Communicate clearly issues and resolutions to peers and subordinates in a meaningful way.
  • Ensures local labelling text is prepared right first time and on-time according to agreed company procedures and objectives.
  • Supports regional labelling team members with health authority questions, requests for further information, preparation, and review of labelling documents prior to submission.
  • Advises Global Labelling Hub and Global Compliance Director regarding any deficiencies or issues.
  • Ensures that supportive documents, not limited to Core Data Sheet or other Reference Label such as USPI, SmPC are obtained in a timely manner to the countries according to local legislation
  • Arranges and updates Local Labelling texts above market on behalf of all impacted markets to ensure their conformity with internal procedures and local legislation.
  • Manages all labelling variations through the Regulatory Information Management System and Track wise Change control environment as needed to show compliance to global submission timelines and valid reason for delay.
  • Liaises with Translation vendors as needed.
  • General knowledge of preparing artwork from labelling text and the interface with Launch Management, Supply Chain and Quality teams.
  • Ensures maintenance of relevant systems according to relevant SOPs.
  • Ensures compliance with all relevant company SOPs
  • Provides support during Medical and Regulatory Audits.
  • Performs other duties as assigned.

Qualifications & competencies for this role are:

  • We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's degree in Science, Medicine or Pharmacy, or another related field
  • Labelling and Regulatory experience
  • Regulatory experience working with Regional Heath Authorities and in-depth Regional Labelling knowledge
  • Highly developed interpersonal, presentation and communication skills with advanced English language capability
  • If you have the following characteristics, it would be a plus:
  • Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy.
  • Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
  • Understand GLC requirements/ processes and EU/ US regulatory requirements.
  • The ability to influence effectively in a matrixed, cross functional team environment

Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.