Regulatory Affairs Expert

19 hours ago


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

Xcenda, LLC is expanding its Regulatory Affairs Services across APAC and seeking a Senior Manager to join their team in Malaysia.

Key Responsibilities
  • Support change applications, including submission strategy, dossier compilation, and content review.
  • Align with functions on variation procedures, deficiency letters, and regulatory compliance.
  • Maintain local RA requirements, manage databases, and communicate with the Health Authority.
  • Cross-functional communication and issue management with Country RA Head.
Required Skills and Qualifications
  • Life Science Degree (Pharmacy degree preferable)
  • At least 5-10 years of relevant experience in Regulatory Affairs
Benefits and Opportunities

Xcenda, LLC offers a range of benefits and opportunities for professional growth and development.



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