Regulatory Compliance Specialist
7 days ago
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
- 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
- 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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