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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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At GSK, our Biopharm CMC regulatory affairs group is responsible for a portfolio of biopharmaceuticals products. As a Manager, Biopharm CMC Regulatory Affairs, you will direct the CMC regulatory activities of multiple projects and dosage forms.
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Director, CMC Regulatory Affairs. 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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R&D CMC Regulatory Affairs Chemical Products Scientist/Sr. Scientist page is loaded. R&D CMC Regulatory Affairs Chemical Products Scientist/Sr. Scientist. 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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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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The individual will support Director and/or Sr. Director Hepatology/Virology to ensure project plans integrate and align with the product strategic plans from matrix teams to maintain leadership in Hepatology/Virology.
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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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SPARC is seeking a Senior Director, Global Regulatory Affairs Strategist to join their team at the North American corporate headquarters in Princeton, NJ. 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.
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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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QUALIFICATIONSA scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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In-depth knowledge of CMC regulatory requirements for Advanced Therapy Medicinal Products and have an understanding of current global and regional trends in CMC Regulatory Affairs for such products.
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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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Director, Regulatory Affairs CMC. 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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Reporting to the Director of Regulatory Affairs, the Senior RA Specialist will collaborate with global team members, cross-functional teams, and stakeholders. You’ve acquired a minimum of 7 years' Regulatory Affairs experience within FDA regulated, complex Medical Device/Software (SiMD/SaMD) environments, including leadership/guidance on global regulatory strategy for 510K’s, CE Marking per MDD, EU MDR (updating Technical Files), Worldwide product registrations, Design Dossiers, PMA, clinical evaluations, Post Market Surveillance and reviewing Marketing Communication materials for promotional purposes.
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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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regulatory affairs jobs Title: sr director Company: Bristol Myers Squibb
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