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Associate Director of Biosimilar Review

Food & Drug Administration

Silver Spring, Maryland 20993
Job Type:
Job Status:
Full Time
Food & Drug Administration
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Job Details

AthAssociatDirectofoBiosimilaReview, the incumbent is responsible for the developmenanconsistenapplicatiooappropriatmethods and approaches fothrevieobiosimilaproductsincludinevaluation of analytical similarity. The Associate Director formulates the policies and procedures formulates the policies and procedures to ensure high quality reviews of biosimilars across therapeutic areas; Serves as the OBP key resource and focal point in the development and implementation of best practices for biosimilar reviews; Actively participates in the Biosimilar Review Committee meetings and deliberations; Actively engages with Division Directors and review management to ensure adequate resources are available for the timely completion of biosimilar reviews and monitors recruitment efforts in this regard.

The Associate Director for Biosimilar Review serves as the principal advisor to the Office Director on all matters concerning quality reviews of biosimilars, including identification of key areas where further guidance development is needed. The Associate Director assumes responsibility with office policy management for the Office’s contributions to multi-disciplinary guidance documents relating to biosimilar product reviews and provides oversight to the writing teams for guidance documents generated by the Office of Biotechnology Products in this area; Develops and implements a comprehensive training program for quality reviewers involved in the review of biosimilar products. These duties require the Associate Director to develop and maintain relationships with regulated industry,academia, and Center/Agency managers and staff to continually guide OBP in the application of state-of-the-art methodologies for the evaluating quality and analytical similarity.

Open to U.S. citizens only.

The Food and Drug Administration is an Equal Opportunity Employer.

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