Friday, November 7, 2008

Customer Service Supervisor

Looking for a customer service supervisor to work in a company located in Central NJ.

Previous dealing with customers and suppliers in a manufacturing enviornment is necessary.


Prepare documents and information for regulatory submissions, including summarizing development information (clinical, manufacturing, analytical testing and data). Interact with the Food and Drug Admin istration concerning submission issues.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

· Provide regulatory guidance (clinical program and submission strategy) as a member of Scientific Affairs Project Teams for developmental projects.

· Prepare INDs, NDAs, ANDAs, application amendments and protocol submissions for new products.

· Review and confirm accuracy of information for regulatory submissions.

· Act as liaison with FDA for follow-up and negotiations on applications

· Review and approve analytical procedures and specifications, formulations, manufacturing instructions, filling instructions and validation reports

· Review and approve clinical protocols

· Review and approve regulatory documentation for clinical drug shipments

· Interact with other departments in the company to obtain technical and clinical information/documentation and analyze for compliance with current regulations.

· Prepare responses to Regulatory inquires.

· Monitor and investigate daily federal register, FDA internet upd

Friday, January 25, 2008

Package Development Engineer

Variet of opportunities in New York and New Jersey looking for experienced package engineers Must have 2+ years of experience and knowledge of cosmetics packaging development. For more information, contact or call 516-466-4120 and ask for Stan.