Associate Director/Director Regulatory Affairs

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POST DATE 9/10/2016
END DATE 10/8/2016

Omega Management Group Nyc, NY

Company
Omega Management Group
Job Classification
Full Time
Company Ref #
360792
AJE Ref #
576132995
Location
Nyc, NY
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Job Title: Associate Director/Director Regulatory Affairs

Overview:
Responsible for all activities related to document preparations for registration and submissions (paper and electronic) and support CMC and QA relevant functions in conjunction with document preparations/controls including Change Control Process. He/she will be project managing the document preparations/dossier compilations by interacting with all functional experts internal/external.
He / she will report to the Regulatory Affairs VP to support all the submission activities.

Responsibilities:
Project manage NDA compilation by providing a comprehensive plan and regulatory input to the project teams. Participate in preparing the clinical data preparations for the New Drug Applications.
Coordinate and participate preparing all regulatory submissions (NDA/MAA, IND/CTA applications, reports, or correspondences, investigator updates, safety reports, and annual reports, as well as assistance in the preparation of IND amendments) and ensure compliance with domestic and international regulations and standards under supervision.
Initiate a document control system, maintain and organize the existing files for easy access.
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
Develop and maintain standard operation procedures or local working practices.
Maintain current knowledge of relevant regulations, including proposed and final rules.