Pharmaceutical Regulatory Affairs Professional

2 weeks ago


Jakarta, Jakarta, Indonesia Wellesta Full time
Company Overview

We are the Indonesian subsidiary of Wellesta Holdings Pte Ltd, Singapore, established to support companies in the Healthcare sector. Our goal is to provide marketing and commercial support for existing operations in Indonesia and multinational corporations entering the market.

Job Responsibilities
  • Regulatory Affairs: Develop and implement regulatory strategies for drug approvals and lifecycle management.
  • Regulatory Submissions: Prepare and submit regulatory dossiers (IND, NDA, ANDA, MAA, CTA, etc.) to relevant health authorities.
  • Regulatory Compliance: Ensure strict adherence to FDA, EMA, MHRA, and other regulatory guidelines.
Qualifications
  • Education: Min. Bachelor's Degree in Pharmacy, Life Sciences, Chemistry, or a related field.
  • Experience: 5+ years in pharmaceutical regulatory affairs.
  • Skills: Excellent communication, leadership, analytical, and problem-solving skills.


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