DIRECTOR - REGULATORY AFFAIRS - Trenton New Jersey

Company: Crescent City Recruitment Group
Location: Trenton, New Jersey
Posted On: 11/16/2024

Position: Director - Regulatory Affairs - -Role Summary: - -Lead regulatory strategy and submissions.Collaborate with R&D, Technical Ops, Clin Dev, etc. to advance the company's drug portfolio in order to ensure commercial success. - -Responsibilities:- Guide development programs to meet both US and global regulatory standards.- Provide strategic regulatory direction from product concept through market launch.- Shape new regulatory pathways in order to benefit stakeholders.Requirements:- 7-12 years of regulatory experience in the pharmaceutical/biopharmaceutical industry.- Proven track record in regulatory leadership, including 505(b)(1), 505(b)(2), 505(j), etc.- Experience in filing and obtaining FDA and international approvals.- Strong regulatory knowledge of drug development including CMC, preclinical, clinical, and post-marketing phases.- Experience working with FDA and other regulatory bodies.Type: direct hire More...

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