Vice President of Regulatory Affairs

VICE PRESIDENT-REGULATORY AFFAIRS


Job Summary:
The VP of Regultory Affairs will oversee the entire Regulatory department, being responsible for worldwide regulatory affairs and clinical and pre-clinical study compliance for the Company.
The position will entail developing and implementing the Company’s regulatory strategy as well as interacting with both internal and external contacts in regards to new product approvals and ensuring compliance as it pertains to Good Clinical Practice (GCP) regulations, Good Laboratory Practices (GLP) regulations, and Good Manufacturing Practice (GMP).
This position offers an excellent salary as well as bonus, benefits, and other incentives. Our client is a publicly traded organization, and was founded over 20 years ago with numerous approved products on the market.
REQUIREMENTS
Qualifications:
1.PhD or MD with 10+ years management experience interacting with government agencies regulating nutraceutical, food, medical food, biological, or pharmaceutical products.
2.Knowledge of the structure of regulatory framework for the major worldwide market areas, especially US, Europe and Asia, necessary.
3.Detailed knowledge of GCP, GLP and current GMP regulations is critical.
4.Strong management and organizational skills.
5.Demonstrated ability and willingness to work within a project team environment.

Travel:
Domestic10 %International10 %