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A growing organization in the Pharmaceutical industry is in need of a Regulatory Affairs Manager based in the greater Princeton NJ area. The Manager will collaborate closely with the Director and VP of Regulatory Affairs, focusing on tasks such as regulatory submissions, initiating and reviewing change controls, and managing labeling activities.
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A hands-on project manager supporting multiple workstreams across the Regulatory Reporting program. Regulatory reporting experience and/or data technology project experience. Manage complex regulatory-driven technology projects across multiple technology, operations, and business units.
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Business partner to R&D, regulatory affairs, and business development teams on product development and drug approval pathways, and on R&D and commercial issues. The Senior Director, Head of Regulatory Law reporting to the VP, General Counsel will provide regulatory counsel to the Rx, Generic, and OTC business at Sun Pharmaceuticals, and its affiliates including Taro Pharmaceuticals.
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The Government Affairs Associate will support PGA’s lobbying and other governmental affairs efforts including developing, implementing and monitoring special projects, strategic business initiatives, research, reporting and logistics.
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The Regulatory Affairs Manager is responsible to assist with organization-wide readiness. The Manager will assist the organization to maintain compliance with standards and regulations for the Center for Medicaid and Medicare Services, NJ Department of Health, The Joint Commission (TJC), and others regulatory bodies.
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Work with CMC cross-functional teams and Regulatory Affairs teams. Requirements: BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred.
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