Regulatory Affairs Manager

Responsibilities:

1. Serve as the primary regulatory representative to Project Teams for assigned projects or products.

2. Provides guidance to Project Teams on steps necessary to comply with newly enacted regulations and guidelines.

3. Interacts with Project Mangers at FDA, when requested by supervisor.

4. In conjunction with supervisor, determines regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational and marketed products.

5. Reviews documents intended for submission to FDA to assure compliance with regulatory standards.

6. For assigned projects, provides oversight and effectively manages any regulatory submissions that are outsourced.

7. Conduct independent regulatory research

Candidate Requirements:

1. Two or more years of regulatory experience in the pharmaceutical industry or equivalent.

2. Advanced degree - Ph.D., M.D., D.V.M. or equivalent.

3. Working knowledge of the drug development process particularly INDs and NDAs), drug laws, regulations, and guidelines.

4. Good understanding of the FDA organization.

5. Good oral and written communication skills including the ability to discuss scientific/technical data and regulatory requirements with senior management and FDA personnel.

6. Good knowledge of ICH guidelines regarding preparation of clinical study reports and investigator brochures.

Compensation

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus, and an attractive benefits package.