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Regulatory Affairs and Labelling Manager

Job description

My client is one of the key global pharmaceutical companies based in the US. They are looking to hire a Regulatory Affairs & Labelling Manager to join their growing team in Singapore. This role would have you be the subject matter expert on regulatory and labelling activities in the assigned regions while providing similar expertise and support to the Global Labelling Hub and Global Compliance Director.

Your responsibilities will include:

  • Ensure labelling for each region/country is prepared correctly based on the regulatory guidelines both internal and external
  • Provide support to team members by answering any health authority questions, including preparation and reviewing labelling documents before submission
  • As a subject matter expert and point of contact - provide input or advice to the Global Labelling Hub on any regulatory guideline, issues, or inadequacies. Additionally, provide support during regulatory audits
  • Keep track of labelling variations to ensure compliance to global guidelines and providing valid reason in case of a delay
  • Work with the Launch, Supply Chain and Quality teams to make sure proper artwork for labelling text can be prepared
  • From time to time onboard and manage labelling associates and work with translation vendors

Key Requirements

  • Bachelor's/Master's degree or higher in Science, Pharmacy, Medicine, or related fields
  • In depth knowledge of regional regulatory requirements pertaining to product labelling
  • Experienced in working with regional health authorities
  • Effective communicator and strong interpersonal and presentation skills are highly desirable
  • Understanding of GLC processes and EU/US regulatory requirements is a bonus

If you believe you fit the requirements for the role, please click APPLY NOW or you can email your CV to

Data provided is for recruitment purposes only. Business License Number: 10C5117. EA Registration Number: R22110278. Regrettably, only shortlisted candidates will be notified.

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