Coordinator II

The primary responsibilities of this position is detailed as follows:
Contribute to preparation of renewal dossiers for Menactra and Menomune
Contribute to completion of Product License Commitments (PLCs) and International Licensing Variation Forms (ILVF) for Menactra
Contribute to preparation of new registrations and variations for Menactra- specifically gathering country-specific elements for the dossiers
Assure submission files, communications, etc. are properly archived and tracked in RA systems on a real-time basis as required

Skills:Knowledge and understanding of United States (FDA) and international regulations/guidelines,
Strong working knowledge of Microsoft Office (especially Word , Excel).
Experience with or ability to learn regulatory affairs department systems (e.g. document management and tracking systems)
Must be able to work independently

Education:BA/BS in Biology, Life Science, (or related field of study preferred), 3-5 years prior Regulatory Affairs experience

Attachments: •

Last updated on Sep 4, 2015