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Regulatory Affairs Expert

3 weeks ago

Taguig, National Capital Region, Philippines Emdgroup Full time

At Emdgroup, we are looking for a talented Regulatory Affairs Expert to join our team in the Asia-Pacific region.

Job Description:

  • We are seeking an experienced professional to execute regulatory submissions in assigned countries, ensuring compliance with local and global requirements.
  • The successful candidate will support regional and global strategies, plans, and communicates registration and plans, generating options to obtain product approvals and supports product changes.
  • Responsibilities include ensuring ready-to-submit dossiers are available as per country requirements through timely dossier compilation, coordinating labeling compliance, and supporting promotional material processes.
  • This role involves tracking regulatory activities for assigned Asian countries and portfolios in relevant company systems according to compliant procedures.
  • The Senior Regulatory Associate - APAC will participate in business meetings with cross-functional teams and external customers, providing active guidance within submission projects.
  • Assistances will be provided in updating, enhancing, and creating internal procedures.
  • The ideal candidate should have thorough knowledge of NDA, CTA/CTD requirements, clinical trial applications, and Common Technical Documents.

About Us:

We are curious minds from diverse backgrounds who come together to drive excellence and innovation. Our inclusive culture fosters growth and opportunities for all employees. We prioritize accessibility and empowerment, allowing everyone to thrive and work towards human progress.