Specialist 4 - Regulatory Affairs

4 days ago


Signal Hill, California, United States Sapta Global Inc Full time
About the Role

Sapta Global Inc is seeking a highly experienced Specialist 4 - Regulatory Affairs to join our team. The successful candidate will be responsible for ensuring regulatory compliance and implementing strategies for Special Project activities.

Key Responsibilities
  • Implement regulatory strategies for Special Project activities in accordance with project schedules.
  • Prepare internal documentation, Technical File updates, EU Design Dossiers, PMA Supplements, and Internal registration support as required by the project.
  • Generate Regulatory Plan documentation and interact with global stakeholders and cross-functional teams to identify regulatory impact.
Requirements
  • BA/BS degree in Life Sciences or related field.
  • Minimum 5 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
  • Excellent communication and project management skills.
What We Offer
  • A competitive salary range of $105,600-$117,360 per year, paid on a W2 basis.
  • A flexible work schedule of 40 hours per week, Monday through Friday.
  • The opportunity to work with a dynamic team and contribute to the success of Sapta Global Inc.


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