Regulatory Compliance Specialist

7 days ago


Somerset, New Jersey, United States Catalent Inc Full time
About the Role

This Senior Regulatory and Compliance Specialist position is available at Catalent Inc in Somerset, NJ. The ideal candidate will have a deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities.

Key Responsibilities
  • Manage the supplier quality program and ensure Supplier Quality Management deliverables are met as required
  • Facilitate and host customer audits at the Catalent Somerset site to ensure compliance with cGMP's, as well as Corporate and site standard operating procedures
  • Facilitate and participate in corporate internal audits to ensure compliance with FDA and applicable international health authority regulations
  • Lead the internal audit program at the site
  • Assist the site in preparing written responses to address the observations for customer audits, internal audits, corporate audits, and regulatory inspections. Ensure responses are completed as committed
Requirements
  • A Bachelor's Degree is preferred with at least 5 years of experience working in the pharmaceutical industry in Quality Assurance, Pharmaceutical Manufacturing, or Compliance
  • An Associate degree or High School Diploma is required with at least 10 years of experience working in the pharmaceutical industry in Quality Assurance, Pharmaceutical Manufacturing, or Compliance
  • Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required
  • Demonstrated experience with customer and internal audits is preferred
Benefits
  • Defined career path and annual performance review and feedback process
  • Diverse, inclusive culture
  • 152 hours of PTO + 8 paid holidays
  • 401K program with match

Catalent offers a competitive salary of $80,000 - $100,000 per year, depending on experience.



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