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Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs. Position Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience.
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Experience 7-10 years pharmaceutical industry experience, including 3 years of experience in CMC Regulatory Affairs projects comprising biologic therapeutics. · Represents Regulatory Affairs activities among cross-functional project teams and functions as the primary contact on CMC regulatory aspects of the projects between Akston and its partner companies.
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Join us as a CMC Regulatory Affairs Specialist, where you’ll put your love of science to work in the Scientific Insourcing Services department. The CMC specialist will also perform regulatory strategy and gap analyses of clients’ materials to assess their needs as they move their drug through clinical development to marketing approval.
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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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The Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates.
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And advise MFA on various legislative and regulatory initiatives before Congress, federal agencies (such as CFTC, SEC, Treasury/IRS, the Federal Reserve Board, and state officials), as well as certain private sector industry groups.
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The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and execution of regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio.
$111,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology Inc., (TOI) projects; provides strategic regulatory guidance especially for CMC during drug development, approval and post approval processes and commercialization, in coordination with internal staff, Japanese colleagues at Taiho Pharmaceutical Corporation (TPC) and external consultants/contractors.
$197,000 - $232,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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If so, this Director of Regulatory Affairs, Small Molecules CMC could be an exciting opportunity to explore. · Will serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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The Director, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will provide centralized management of Constellation’s advocacy at the Federal Energy Regulatory Commission (FERC) and other organizations, as appropriate, including all communications with FERC, internal development of positions, participation in proceedings, preparation and filing of pleadings, and informal advocacy.
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Regulatory Affairs Chemistry, Manufacturing, And Controls (CMC) Internship Overview. Regulatory Affairs (RA) CMC develops and executes regulatory strategies in Chemistry, Manufacturing, and Controls (CMC) which use science to tell the story of our products in a clear and compelling way that leads to those products reaching patients quickly.
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The Senior Regulatory Affairs Specialist will be responsible for projects by leading biologics CMC regulatory submissions, reviews and approves advertising/promotional materials, provides regulatory input into change controls and CAPAs and support audits/inspections to ensure full compliance for US S+N site.
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Regulatory Affairs Manager *PC Regulatory Affairs - Waltham MAAt Miltenyi Biotec, 3, employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies.
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You Will Assist the Vice President, Policy & Government Affairs (PGA) in developing and implementing federal legislative and regulatory advocacy efforts that advance SCAN's mission and federal policy positions.
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Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) as directed by the Senior Director CMC Regulatory Affairs. They are seeking a Regulatory CMC Director or Associate Director who can develop CMC regulatory strategies and prepare CMC submissions for their clinical-stage small molecule drug programs and approved product.
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regulatory affairs jobs Title: regulatory affairs specialist Company: Jazz Pharma
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