Global Regulatory Strategy Manager

2 weeks ago


Jakarta, Jakarta, Indonesia Wellesta Full time
Job Function

As a Global Regulatory Strategy Manager, you will be responsible for developing and implementing effective regulatory strategies for drug approvals and lifecycle management.

Key Responsibilities
  1. Develop Regulatory Strategies: Collaborate with cross-functional teams to develop and implement regulatory strategies that meet global regulatory requirements.
  2. Prepare Regulatory Submissions: Prepare high-quality regulatory submissions (IND, NDA, ANDA, MAA, CTA, etc.) for review and approval.
  3. Ensure Regulatory Compliance: Ensure strict adherence to FDA, EMA, MHRA, and other regulatory guidelines to maintain product approval and minimize risks.
Requirements
  • Education: Min. Bachelor's Degree in Pharmacy, Life Sciences, Chemistry, or a related field.
  • Experience: 5+ years in pharmaceutical regulatory affairs, preferably in a similar role.
  • Skills: Excellent communication, leadership, analytical, and problem-solving skills.


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