Friday, November 7, 2008

Regulatory

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