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Head of Regulatory Operations

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia Xcenda, LLC Full time

Xcenda, LLC is a leading provider of Pharmaceutical Solutions. We are seeking a Senior Manager, Regulatory Affairs to join our team in Malaysia.

Job Summary

The successful candidate will be responsible for managing the life cycle of medicinal products, ensuring compliance with Health Authority requirements. This includes supporting change applications, dossier compilation, and content review of CMC/Labelling documentation.

Main Responsibilities:

  • Support change applications including submission strategy, dossier compilation, and content review of CMC/Labelling documentation.
  • Manage the life cycle of medicinal products, ensuring compliance with Health Authority requirements.
  • Review of promotional materials, ensuring compliance with regulatory requirements.
  • Cross-functional communication to all relevant departments in relation to regulatory strategy and submission.

Requirements:

  • Life Science Degree (Pharmacy degree preferable).
  • At least 5-10 years of relevant experience in Regulatory Affairs.
  • Experience in artwork management and supply strategy.
Benefits

We offer a range of benefits that support the well-being of our team members. These include benefit offerings outside the US that vary by country and will be aligned to local market practice.