Current Job Openings

PTS Advance is actively hiring a Regulatory Specialist for our client in Bergen County, NJ. Our client has a mission to develop new and innovative ideas, utilize technology, and share their experience globally. Offer your regulatory knowledge as a part of a company that is continuing to offer remarkable products and services.
We are searching for a talented individual who can share their knowledge of the regulatory environment in pharmaceuticals.
Duties
  • Offer regulatory guidance and management for products, incorporating analysis of guidance and suggestions for how to apply. 
  • Work cross-functionally with external business partners, clients, and internally with relevancy to regulatory affairs.
  • Prepare and file submissions, updates, annual reports, and other documents to FDA.  
  • Institute and maintain electronic system for submitting documentation to FDA.
  • Communicate and collaborate as needed with FDA or other health authorities. Organize and deliver required documentation.
  • Implement a tracking system to ensure FDA deadlines are timely and compliant.
  • Offer support to Quality Assurance including investigations, CAPAs, review of batch records and approval of Certificates of Compliance.
  • Complete external audits of laboratories, suppliers, and other facilities. Prepare audit reports and follow-up on actions. 
  • Assist in on-site regulatory agency inspections and client audits. Write responses to regulatory agencies regarding inspections and client audits when applicable.
  • Carry out multiple priorities and projects in a quick-moving environment.
  • Other duties as needed by management.
Key Skills
  • Must be detail-oriented with excellent organizational and time management skills.
  • Ability to complete regulatory tasks independently, accurately, and timely.
  • Demonstrates strong knowledge of FDA regulations and guidelines. Knowledge of cGMPs.
  • Works well collaboratively; a team player.
  • Ability to offer guidance and make needed recommendations. 
  • Excellent verbal and written communication skills.
  • Strong use of computer skills.
Requirements
  • Must have a degree in Pharmaceuticals, Chemistry, or related life-sciences field.
  • Minimum of 6 years in a pharmaceutical industry.
  • Minimum of 4 years specializing in Regulatory Affairs or Quality Assurance.
  • Previous experience in direct contact with the FDA preferred.
  • Understanding of Current Good Manufacturing Practices and FDA guidelines.
 
We are actively interviewing! Please follow the listed steps or send your resume to Brittany.antonellis@ptsadvance.com to apply.