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CMC Regulatory Manager

Company: US Tech Solutions
Location: New Brunswick
Posted on: June 20, 2020

Job Description:

Job Title:--CMC Regulatory Manager Location:--New Brunswick, New Jersey Duration: 12 months Client : Pharmaceutical CompanyJob Description:Represent regulatory CMC--on matrix teams while providing strategic guidance related to current regulatory requirements and expectations for marketing applications--and/or clinical trial applications for small molecule projectsReview and provide regulatory assessments on change controls (commercial and/or development products)Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documentsManage collaborative relationships with diverse teamsUtilize electronic systems for dossier creation and tracking regulatory informationEducation, Experience, Skills:Minimum of Bachelor's Degree, scientific discipline, with minimum of 4-6+ years of related experienceCMC regulatory experience, including post-approval experience desiredKnowledge of CMC regulatory requirements during development and post-approvalKnowledge of pharmaceutical development, including drug substance and drug product and analytical methods.Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently--Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timelinessAbility to interpret global regulations and guidanceStrong oral and written skillsProficient with electronic systemsOccasional Travel Required

Keywords: US Tech Solutions, New Brunswick , CMC Regulatory Manager, Executive , New Brunswick, New Jersey

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