Regulatory Affairs Manager

Regulatory Affairs ManagerSomerset, 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 experienceIn-depth knowledge of ISO 15378:2017Strong background of applicable government regulationsKnowledge of EU, Canada, and India filings a plusKnowledge of NHS and Health Canada a plusAbility to multi-task with patienceSelf-motivated and self-disciplinedExceptional communication, interpersonal, analytical, and problem-solving skills40-50% travel; current passport requiredRegulatory Affairs Manager - our client offers:Collaborative, innovative, and passionate team who is there to help you succeed and growWell-established, stable, and successful company$115-125k base plus full benefitsRegulatory Affairs Manager Responsibilities:Promotes a proactive safety culture by encouraging hazard reporting, improvement suggestions, and employee ownershipIdentifies and corrects safety gaps; ensures compliance with plant safety, housekeeping, and 5S standardsVerifies incoming/outgoing goods meet safety and quality standardsFollows GMP/GDP practices and supports pharmaceutical market growth through client engagementTrains staff on regulatory policies and ensures compliance with industry/government standardsResponds to regulatory and customer inquiries; stays current on regulations and trendsBuilds and maintains strong relationships with regulatory agencies, customers, and suppliersHow to Apply:Please contact Kara Onorato, International Search Consultants at KaraO@.

Created: 2025-05-22