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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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Job DetailsThe 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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As a key member of our legal department, the Senior Manager of Regulatory Affairs/In-House Counsel will play a crucial role in managing regulatory compliance, with a primary focus on collections and litigation.
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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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Director, CMC Regulatory Affairs – Biologics. Head of CMC Regulatory Affairs – Small Molecules. Regulatory Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.
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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 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 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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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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The Associate Director, Regulatory Affairs will establish and grow internal CMC regulatory activities, providing strategic management and content plans to support Vyriads gene therapy product development, registration, and post-approval strategies.
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POSITION SUMMARY Reporting to the Managing Counsel, Health Affairs, Privacy & Data Protection Law, the Principal Counsel - Health Regulatory provides primary legal support to the University's medical centers and health sciences schools on complex and high impact healthcare regulatory analysis.
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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 Today - UpvoteDownvoteShare Job
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Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams. Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
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Recruiter: Spencer Gregory Hale Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC Team Purpose: The Rhythm Management (RM) Regulatory Affairs leadership team is a strategic partner that delivers innovative, efficient, and sustainable business and regulatory solutions for customers throughout the product lifecycle.
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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 jobs Company: Genesis Healthcare
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