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Post Approval CMC Regulatory Specialist

Rahway, NJ

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nnJob DescriptionnPOST APPROVAL CMC REGULATORY SPECIALISTWEST POINT, PA / RAHWAY, NJ  Required Skills:  tMinimum BS, Chemistry/Biochemistry, Chemical Engineering, Pharmacy, Biology or related science. tA minimum of 5 years in the Pharmaceutical Industry with post approval CMC regulatory strategy, regulatory submission and related experience. tA strong pharmaceutical background with in-depth knowledge of CMC regulations and guidance, and exposure to developing global regulatory strategies for post approval changes is required. tStrong post approval authoring experience.tExperience creating content, not just working off of templates.tThe candidate will have demonstrated ability to be a strong team member both within and outside the department with the ability to drive projects to completion and provide innovative new solutions to changing deliverables. tThis position requires good organizational, communication, electronic systems and project management skills. tThe candidate will be required to implement the CMC submission activities (planning, preparing, review, and submission), and to ensure the accuracy and clarity of the submissions. Project Description:  tThe candidate will be responsible for preparing CMC regulatory submissions for client marketed drug products. tThe position will have responsibility for executing regulatory strategy for anticipated analytical, manufacturing and packaging changes, compilation of post approval regulatory submissions including annual reports, renewals, supplemental applications, variations and other maintenance dossiers and coordination of responses to health authority questions and comments within agreed upon timelines. tStrong interaction with Technical Operations personnel at manufacturing sites and other key partners both internal and external to the company. tThis position requires the ability to independently manage multiple projects in alignment with company objectives.t  This 5 month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: ****  ALPHA'S REQUIREMENT #18-01118MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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