Associate Director of Regulatory Affairs

Coastal Search Associates, LLC

  • Gaithersburg, Maryland

  • Posted Published: July 21, 2020
Gaithersburg, Maryland
Job Type
Key SKill
Regulatory Affairs biologics industry experience and vaccine experience required.
No of Openings
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Job Description

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.

Job Requirements:

Advanced Degree.

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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