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Community affairs Jobs in Paterson, NJ
Regulatory Affairs Associate
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On-Board CompaniesSomerset, NJOn-Board Scientific is hiring a Regulatory Affairs Assistant!
For immediate consideration please send your resume to
Subject Line : Position Title and State you are Located 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 k.
Position Details :
Position Type : year contract with additional opportunity contingent upon performance and continued business need
Job Location : Somerset, NJ
Shift : st shift
Benefits :
Compensation : $-$ 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 (, 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 :