Regulatory Affairs Specialist

14 hours ago


Jakarta, Jakarta, Indonesia Wellesta Full time
Job Overview

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Wellesta CPI. The successful candidate will be responsible for developing and implementing regulatory strategies for drug approvals and lifecycle management.

Key Responsibilities
  1. Develop and implement regulatory strategies for drug approvals and lifecycle management.
  2. Prepare and submit regulatory dossiers (IND, NDA, ANDA, MAA, CTA, etc.).
  3. Ensure compliance with FDA, EMA, MHRA, and other regulatory guidelines.
Requirements
  • Min. Bachelor Degree in Pharmacy, Life Sciences, Chemistry, or a related field.
  • Experience: 5+ years in pharmaceutical regulatory affairs.
  • Strong knowledge of global regulatory frameworks (FDA, EMA, ICH, etc.).


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