Regulatory Affairs Associate
Responsibilities of the Regulatory Affairs Associate:
- Participate in the preparation of documentation packages for regulatory submissions (including IND, CTA, etc.) to the FDA and other regulatory agencies.
- Formats, edits, coordinates and reviews regulatory documentation for inclusion in INDs, CTAs, and other worldwide submissions.
- Compiles documentation for submissions to FDA and foreign regulatory agencies.
- Maintains regulatory documentation including submissions to and correspondence with each governing authority.
- Reviews clinical and technical documentation for regulatory compliance.
Requirements of the Regulatory Affairs Associate:
- B.A. or B.S. degree in an appropriate scientific field.
- Must have 2+ years experience in a Regulatory Affairs/Regulatory Operations.
- Previous participation in preparing regulatory submissions (IND, CTA, BLA, etc.) to the FDA and EU Regulatory Authorities.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.