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We invested in new offices, sector teams and practice groups including higher education; foundations and nonprofits; 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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Minimum 5 years in Regulatory Affairs within any of the following industries: pet food, food, OTC drugs, medical devices or pharmaceuticals; Create and foster a climate of teamwork and effective working relationships both within Regulatory Affairs and with our internal business partners: Quality, Marketing, Legal, New Product Innovation, Science & Technology, Professional Veterinary Affairs, Supply Chain, and others to achieve the synergy needed to effectively work as a team and promote the business.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) A solid understanding and experience in drug development including early and late development is highly preferred.
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Collaborate with internal project team to facilitate IND/CTA document authoring and review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory.
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Senior Regulatory Affairs SpecialistWHO WE ARE:NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers.
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You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance.
$205,700 - $266,200Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The three (3) years of experience as Regulatory Specialist and/or Compliance Analyst must have included the preparation and submission of regulatory compliance documents for a financial services institution with a focus on LATAM regulatory strategy, compliance, audit, and risk control framework.
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Interact regularly with multi-functional staff from Analytical Sciences & Quality Control, Drug Substance Process Development, Manufacturing Technical Services, Quality Assurance, and/or CMC Regulatory Affairs to support progress of the program and preparation of source documentation supporting BLA.
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Maintain a thorough understanding of CNB's Internal Controls Management Policy and Standards, control testing methodologies, and related regulatory and compliance standards, including but not limited to enterprise risk management, data governance, third party risk management, model risk management, business continuity, fraud risk management, and associated regulations, guidance, and regulatory expectations.
$92,114 - $156,880 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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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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The Data and Systems Architect works closely with the Finance, Power Supply, and Customer Care teams and will stay current with CPA’s core business by continuously collaborating with teams overseeing Communications and Marketing, Government Affairs, Regulatory Affairs, and Strategy.
$153,885 - $221,594 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.
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The successful candidate will work collaboratively with the dynamic Federal Legislative Affairs team, as well as regulatory and business teams, to develop policy positions, formulate lobbying strategies, and coordinate Hill outreach to drive desired outcomes on critical issues.
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Outside of the RWE organization, the VP will work with leaders from other CMAO functions, Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HV&E , Legal/Compliance, Worldwide Medical and Safety, and others to achieve research and business objectives.
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regulatory affairs change control systems jobs Company: Oruka Therapeutics
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