DIRECTOR - REGULATORY AFFAIRS
Company: Crescent City Recruitment Group
Location: Trenton
Posted on: November 15, 2024
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Job Description:
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
Keywords: Crescent City Recruitment Group, Hoboken , DIRECTOR - REGULATORY AFFAIRS, Executive , Trenton, New Jersey
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