Regulatory Compliance Specialist

7 days ago


Jakarta, Jakarta, Indonesia Wellesta Full time
Job Description

At Wellesta CPI, we are seeking an experienced Regulatory Compliance Specialist to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with global regulatory frameworks.

Responsibilities
  1. Develop and Implement Regulatory Strategies: Collaborate with cross-functional teams to develop and implement effective regulatory strategies for drug approvals and lifecycle management.
  2. Prepare and Submit Regulatory Dossiers: Prepare and submit high-quality regulatory dossiers (IND, NDA, ANDA, MAA, CTA, etc.) to relevant health authorities.
  3. Regulatory Compliance: Ensure strict adherence to FDA, EMA, MHRA, and other regulatory guidelines to maintain product approval and minimize risks.
  4. Stay Up-to-Date with Regulatory Changes: Monitor regulatory updates and provide internal training on compliance requirements to ensure seamless integration.
Requirements
  1. Education: Min. Bachelor's Degree in Pharmacy, Life Sciences, Chemistry, or a related field.
  2. Experience: 5+ years in pharmaceutical regulatory affairs, preferably in a similar role.
  3. Knowledge: Strong understanding of global regulatory frameworks, including FDA, EMA, ICH, and other relevant regulations.
  4. Expertise: Proven experience in preparing regulatory submissions and handling product approvals.
  5. Skills: Excellent communication, leadership, analytical, and problem-solving skills.


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