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Sr.Regulatory Affairs Associate/Manager

at Company: Antigenics, Inc. in Job Category: Regulatory
posted on 10/7/08 12:00am

Senior Regulatory Affairs Associate/Manager

Responsibilities:

Coordination, preparation and review of document packages for regulatory submissions to the FDA and other government agencies, as well as license applications and annual registrations. Responsibilities: Research regulatory issues and review clinical, manufacturing and other documentation for regulatory compliance. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Keep abreast of additions/changes to requlations and guidelines and evaluate relevance to company and product interests. Identify and develop regulatory systems and/or procedures that would improve regulatory productivity. Maintain departmental SOPs and databases and perform electronic publishing of submissions.

Qualifications:

BA/BS or equivalent, with 3-5 years regulatory or related experience. Knowledge of global guidelines. Biologics RA experience is preferred, and previous experience in IND/BLA/MAA applications is required. Requires excellent organizational and communication skills and a flexible team oriented attitude. Strong attention to detail and the ability to handle multiple tasks. Helpful to have previous experience in electronic publishing software.

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