Regulatory Affairs Associate - On-Board Companies

About Us:
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer benefits as well as 401k.

Position Details:
Position Type: 1 year contract with additional opportunity contingent upon performance and continued business need
Job Location: Somerset, NJ
Shift: 1st shift
Benefits:
Compensation: $25-$35 per hour based on previous experience

The Regulatory Assistant needs to exhibit working knowledge of pharmaceutical operations. Time and Project management skills with attention to details and the ability to plan, prioritize work, while balancing multiple projects. The Regulatory Assistant will need to utilize scientific and technical information to ensure that documents produced are consistently accurate and complete.

Responsibilities:
• Publish individual regulatory documents are needed (e.g., convert to PDF, bookmark, hyperlink, making sure that the documents are created)
• Running weekly, monthly submission report, archives and maintains all electronic submissions in accordance with established practices and procedures
• Maintain and update various regulatory databases
• Maintain all SPL submissions made by the team and communicate timely about any unsuccessful submissions
• Creates GDUFA, PDUFA, BSUFA cover sheets
• Maintains litigation products folder
• Gather information requested by sales and marketing team, finance team and pipeline management team etc.
• Miscellaneous responsibilities as assigned

Qualifications:
• Bachelor’s or Master’s degree in Science
• 5+ years of related pharmaceutical or biopharmaceutical industry experience with a previous regulatory submissions experience

Apply Today!
www.onboardusa.com

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry. Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America. The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC. On-Board’s Mission is to provide “Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.” On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

JD# 24-01877
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