Regulatory Affairs Specialist- PERM placement located in New Providence, NJ!!

Kelly Clinical Resources is seeking a Regulatory Affairs Specialist for a PERMANENT placement position with a major healthcare provider located in New Providence, NJ.

JOB RESPONSIBILOTIES:
The Regulatory Affairs Specialist will be responsible for all aspects of global regulatory submissions for assigned, marketed drug products, with emphasis on regulatory compliance and life cycle management.

Role for assigned products may be 'Global Product Owner' (GPO) or 'Local Product Owner' (LPO), depending on therapeutic area and workload.

As GPO, he/she will have global regulatory responsibility for all aspects of his/her assigned drug products.

In addition to the GPO role, this position will also be responsible for preparation and submission of drug applications and supplements to existing products.

This person will work closely with the facility and business management teams to assist in resolving technical issues and develop regulatory strategies as needed.

JOB REQUIREMENTS:
Bachelor's degree in relevant scientific discipline is required.

Minimum 5 years regulatory experience.

The Candidate must demonstrate the ability to learn and interpret regulations and guidelines and understand technical product information to assure regulatory requirements are being met for marketed products.

Excellent interpersonal and collaboration skills and ability to identify and proactively resolve problems are required.

Strong organizational skills, including project management are required.

Commitment to teamwork, quality and customer satisfaction are essential.

Excellent written and verbal communication skills and computer literacy required.


QUALIFIED APPLICANTS ARE ENCOURAGED TO CLICK "APPLY NOW" FOR IMMEDIATE CONSIDERATION!

Kelly Scientific Resources(KSR) is the scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. We provide scientific staffing services on a temporary, project and full-time basis to a broad spectrum of industries including Pharmaceutical, Biomedical, and Clinical Research.Kelly Services is an Equal Opportunity EmployerContact?Information?:.2525 Route 130
Cranbury?NJ?08512-3513