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.
- 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.
- 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.
- 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.email@example.com to apply.