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The Judge Group

The Judge Group is looking for a Sr. manager/Associate Director Reg Affairs  #FindJobPagosaSprings #EmploymentOpportunityInPagosaSprings #DirectorJobsPagosaSprings #ManagerJobsPagosaSprings

Location: REMOTEDescription: Our client is currently seeking a Sr. manager/Associate Director Reg Affairs who has strong pre-IND experience “ and demonstrating critical thinking abilities and due diligence knowledge, and will:  Collaborate with cross functional team members focused on Global Development Projects.  Work with senior members of the US Regulatory Affairs staff to develop Regulatory Strategy and Process Improvement initiatives. Participate in clinical development program planning and execution, study teams, and study-related activities. Prepare components of IND and NDA submissions and write correspondence, meeting requests and information requests. This job will have the following responsibilities: Complete cover letters, FDA Form 1571 and other documentation for submission to FDA as needed. Interpret and advise regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization in order to maximize the business benefit and maintain regulatory compliance. Establish contact with the FDA as required to support developmental programs. Manage regulatory timelines, interactions, and regulatory-specific study activities with CRO organizations as needed. Qualifications & Requirements:Bachelors degree in Science (e.g. Chemistry, Pharmacy, Biochemistry). Masters degree in Science related field strongly preferred. Minimum of 4 years of Pharmaceutical industry experience with a combined focus of Clinical Development Operations and Regulatory Affairs. Working knowledge and experience in regulatory submissions and product life cycle management. Strong pre-IND experience and Phase I clinical development through NDA filing is sought (though not necessarily with same compound).Contact: [ Link removed ] – Click here to apply to Sr. manager/Associate Director Reg AffairsThis job and many more are available through The Judge Group. Find us on the web at [ Link removed ] – Click here to apply to Sr. manager/Associate Director Reg Affairs Recommended SkillsNon Disclosure Agreement (Intellectual Property Law)Pre Clinical DevelopmentChemistryRegulatory ComplianceBusiness Process ImprovementTimelinesRecommended JobsDirectorDirector Of Regulatory AffairsAtlanta,GaDirector Of Regulatory Affairs, Atlanta,GaSr. manager/Associate Director Reg AffairsThe Judge GroupREMOTEFull Time
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})Director of Regulatory AffairsGreene ResourcesAtlanta
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})Director of Regulatory Affairs – Minnetonka, MN or TelecommuteUnitedHealth GroupAtlanta
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