Reguatory Associate - Robsco, Inc.

Position Description

Position: Regulatory Affairs Associate
Location: Melville, NY


Job Responsibilities:
• 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 updates and trade press notices for changes in regulations or regulatory policy that may impact internal operations.

Job Requirements:
• Bachelor degree required, preferably in a scientific discipline
• 3-5 years pharmaceutical experience required
• Experience making submissions to the FDA
• RAPS membership a plus

How to Apply

Application Instructions / Send a Resume