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QUALIFICATIONSA scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in executing and implementing CMC regulatory strategies for a given molecule.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Serve as the Plan’s internal Compliance point of contact for Regulatory Affairs matters. Under the direction of the Manager, Regulatory Affairs assist in preparing the Plan for regulatory audits.
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PRIMARY RESPONSIBILITYThis role will lead the Regulatory Operations activities within Global Regulatory Affairs. This role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs, and supporting development of Regulatory Operations procedures and practices.
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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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POSITION OVERVIEW: The Regulatory Affairs, Accreditation & Safety Specialist (RASS) provides regulatory and safety expertise as related to Joint Commission, CMS, Oregon Health Authority, Pharmacy Board, OSHA, and other regulatory agencies.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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The Director of Risk Management and Regulatory Affairs (Patient Safety Officer/Privacy Officer) serves as an accessible resource to the hospital and community on risk management and regulatory issues.
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Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks.
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We invested in new offices, sector teams and practice groups including investor engagement; shareholder activism; governance; regulatory and public affairs, including geopolitical; crisis; litigation; social issues including climate change and diversity, equity and inclusion; cybersecurity, data and privacy; employee engagement; digital communications; opinion research and analysis, and; creative services.
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I-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance and Bioinformatics. Lead Mechanical Engineer / LME. Lead Mechanical Engineer opportunity to work for a top 10 premier CDMO. This position is working on a well funded site that will be growing over the next 3 years.
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Lead Mechanical Engineer - Lyophilizers. Interpret, modify and create engineering drawings; Piping and Instrumentation Diagrams, Piping Drawings, Layouts, Isometrics, Building Mechanical, Instrumentation and Electrical Drawings.
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The Regulatory Specialist under the supervision of the Director of Accreditation and Regulatory Affairs has responsibility for site visit preparation, coordination of site visit logistics and response, as well as assist in preparing report-out to management of major regulatory changes and issues of mock or real survey results.
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Provide regulatory guidance, general issue management and strategic stakeholder engagement support to Corporate Affairs and business leaders. Humana Director Public Policy, State Affairs Helena , Montana Apply Now Become a part of our caring community and help us put health first.
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Communications / Contacts Internal - Departmental staff, business unit leaders/representatives, accounting managers, treasury and finance personnel, regulatory affairs cost of service department staff; and BHE corporate consolidations External - Federal Energy Regulatory Commission (FERC), Corporate Noteholders, Kansas Dept of Health & Environment, Environmental Protection Agency, auditing firms, IRS, pipeline journals.
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Responsible for approval of medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas. Board Certified in therapeutic area and US fellowship training, or MD with 2-4 years’ experience in within the pharmaceutical industry including 2 years in-house Medical Affairs role, or PhD or PharmD with 5 years’ experience within the pharmaceutical industry, including experience in the therapeutic area and 3 years in an in-house Medical Affairs role; MD preferred.
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regulatory affairs jobs Title: regulatory affairs project Company: Anthem
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