Regulatory Affairs Manager
Somerset NJ
ISCs 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 will focus on pharmaceutical packaging compliance and support customer interactions.
Regulatory Affairs Manager Qualifications:
- 5 years of Pharmaceutical Regulatory Affairs experience
- Indepth 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 multitask with patience
- Selfmotivated and selfdisciplined
- Exceptional communication interpersonal analytical and problemsolving skills
- 4050 travel; current passport required
Regulatory Affairs Manager our client offers:
- Collaborative innovative and passionate team who is there to help you succeed and grow
- Wellestablished stable and successful company
- $115125k 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 .
Required Experience:
Manager