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Dorsey is seeking a Regulatory Affairs Associate with four to six years of experience to join our Anchorage office. This associate will have the opportunity to work on a wide variety of issues and matters, including corporate and municipal governance, contracting, financings, real property, proxy and proxy statements, and annual meetings (parliamentarian and inspector of elections), in addition to commercial telecommunications and merger and acquisitions.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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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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Responsibilities The Regulatory Affairs Associate ensures proper oversight of investigator-initiated clinical research and lab-based studies. The Regulatory Affairs Associate will serve as a liaison for PI(s)/study team and various internal/external regulatory oversight groups.
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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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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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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 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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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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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.
$295,290 - $382,140ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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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: sr regulatory affairs associate Company: Medtronic Inc
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