Regulatory Affairs Manager

Somerset, NJ

ISC’s team of Manufacturing Recruiters is partnering with a leading manufacturer to identify an experienced Regulatory Affairs Manager for their Somerset, NJ location.

The Regulatory Affairs Manager will develop and monitor the activity regarding regulations and SOP’s. They will focus on pharmaceutical packaging compliance and support customer interactions.

Regulatory Affairs Manager Qualifications:

• 5+ years of Pharmaceutical Regulatory Affairs experience
• In-depth knowledge of ISO 15378:2017
• Strong background of applicable government regulations
• Knowledge of EU, Canada, and India filings a plus
• Knowledge of NHS and Health Canada a plus
• Ability to multi-task with patience
• Self-motivated and self-disciplined
• Exceptional communication, interpersonal, analytical, and problem-solving skills
• 40-50% travel; current passport required

Regulatory Affairs Manager – our client offers:

• Collaborative, innovative, and passionate team who is there to help you succeed and grow
• Well-established, stable, and successful company
• $115-125k base plus full benefits

Regulatory Affairs Manager Responsibilities:

• Promotes a proactive safety culture by encouraging hazard reporting, improvement suggestions, and employee ownership
• Identifies and corrects safety gaps; ensures compliance with plant safety, housekeeping, and 5S standards
• Verifies incoming/outgoing goods meet safety and quality standards
• Follows GMP/GDP practices and supports pharmaceutical market growth through client engagement
• Trains staff on regulatory policies and ensures compliance with industry/government standards
• Responds to regulatory and customer inquiries; stays current on regulations and trends
• Builds and maintains strong relationships with regulatory agencies, customers, and suppliers

How to Apply:

Please contact Kara Onorato, International Search Consultants at [email protected].