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Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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They will be responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) under the supervision of the Regulatory Affairs Manager.
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Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
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Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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The applicant should join SPARC to take the leadership position for clinical regulatory affairs strategy in a dynamic and rapidly growing novel drug discovery company. The position is to provide regulatory affairs strategic leadership for SPARC and supported Sun novel drug development programs.
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The Principal Scientist provides regional scientific and regulatory expertise and leverages scientific networks to enable the development and execution of Mars Wrigley (MW) Scientific and Regulatory Affairs (SRA) strategy.
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Preferred 10 years' experience in regulatory & scientific affairs focused on ingredient issues management in food products and packaging and/or related product categories (such as food supplements, cosmetics) with proficiency in regulatory affairs and compliance.
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You will provide global product stewardship and regulatory affairs services for a line of chemical products that support Videojet printers. Manage our SDS, label, and regulatory affairs systems.
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This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Senior Regulatory Affairs Specialist-Remote Based-West Coast.
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Build the Regulatory Operations infrastructure and oversee development of standard operating procedures, training materials, and job aids with respect to Regulatory Affairs and Operations.
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Under the direction of the Manager, Regulatory Affairs assist in preparing the Plan for regulatory audits. Under the direction of the Manager, Regulatory Affairs, the Analyst I - Regulatory Affairs (Policy & Communications) has a general knowledge of and performs key centralized regulatory activities of moderate difficulty for the Compliance Department.
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Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
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Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.
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The Regulatory Affairs Manager will work out of our Maple Grove, MN location for our Electrophysiology division. Regulatory Affairs Manager - Electrophysiology page is loaded.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Abbvie
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