Associate Director of Regulatory Affairs
Coastal Search Associates, LLC
- Posted Published: July 21, 2020
This is a new position based on growth. My client wants a person who is self-sufficient and wants to grow with this Public clinical stage
Infectious Diseases Corporation located in the Gaithersburg MD area.
The Director of Regulatory Affairs will lead the development of regulatory strategy and manage all regulatory submissions and interactions for this Public Maryland Pharma Company.
You will provide guidance to the Quality Organization and both internal and external regulatory activities.
5-10 years of regulatory affairs biologics industry experience and vaccine experience required.
Direct interaction experience with FDA required.
Thorough knowledge and practical application of domestic and international regulations including cGMPs, GLP, GCP and ICH.
Experience with submissions via eCTD .
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