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Director - Regulatory Affairs

1 month ago

new jersey, United States Apple & Associates Full time

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