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Understands and translates into evidence solutions the strategic direction of the brand in partnership with the integrated brand teams focusing on the impact of evidence generation to solve complex issues + Partners with internal stakeholders where applicable such as development, on market cross functional teams, Medical Affairs, Market Access, and others, to execute on evidence needs of the asset.
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As a Manager, Biopharm CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms. At GSK, our Biopharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals products.
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Dorsey is seeking a Regulatory Affairs Associate with four to six years of experience to join our Anchorage office. Among Dorsey’s many distinguished alumni are U.S. Supreme Court Justice Harry Blackmun, noted law professor and scholar William Prosser, Minnesota’s first woman judge Betty Washburn, former U.S. Vice President and Ambassador to Japan Walter Mondale, U.S. Senator Amy Klobuchar, former Corporation Counsel of the City of New York Zachary Carter, and U.S. Secretary of Agriculture Tom Vilsack.
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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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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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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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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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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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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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As a staff member of CMC Regulatory Affairs Department of Japan Development Division, a person in charge who is willing to contribute in CMC Regulatory Affairs (RA) tasks from initial stage of new drug development to NDA filing and the approval, addition of dosage form, and change controls.
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Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead for support with opportunities for regulatory innovation / promote the use of novel approaches within project teams to resolve issues and problems.
$295,290 - $382,140ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Job Title: Regulatory Affairs Manager. Provide CMC regulatory strategy input and expertise in investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global regulatory requirements and guidance.
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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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Interns will work closely with MCRA experts and mentors to gain critical hands-on knowledge in Regulatory Affairs, Biocompatibility, and Toxicology. MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization.
InternExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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10+ 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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regulatory affairs jobs Title: regulatory affairs project manager Company: Ppd
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