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Large MLTC program with locations around NYC, is currently seeking an experienced Regulatory Affairs Associate to join their dynamic and dedicated team. Regulatory Affairs Associate – MLTC Program - Hybrid.
$125,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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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.
$100 - $113 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function's Executive Office.
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Block is looking for an experienced policy and regulatory strategist to serve as our Head of Regulatory Affairs. Maintain fluency on a variety of regulatory and policy issues at the intersection of financial and technology policy, including financial regulation, consumer protection, tax, cryptocurrencies, AI/machine learning, intellectual property, and privacy.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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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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May oversee and direct the work of other Regulatory Affairs professionals. Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
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Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
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The University of Cincinnati, Hoxworth Blood Center is recruiting for a full-time (100 % FTE), Director, Quality Assurance / Regulatory Affairs, to oversee and direct the coordination of quality assurance and regulatory compliance for the Cellular Therapy, Therapeutic Apheresis, and Transplantation Immunology divisions.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We’re a leader in staffing Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, HEOR, Market Access, and Sales & Marketing roles. Medical Science Liaison, Hematology/Oncology (Northern CA) TMAC (TMAC Direct) - San Francisco, CA, United States Tagged: MSL, Medical Affairs, Medical Science Liaison, Oncology, Hematology , Field Medical , Pharmaceutical, TMAC Direct Hire Hematology/Oncology MSL Expansion – Top BioPharma CompanyTMAC’s direct-hire service, formerly known as TMAC Direct, is an executive search firm and Pharma’s Complete Recruiting Resource.
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Works collaboratively with Risk, Legal, Billing and Regulatory Compliance, Accreditation, and Regulatory Affairs leadership to comply with state and national norms of legal and regulatory health care compliance.
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This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global/regional/local HEOR leaders, Department Heads, TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access.
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The position is responsible for supporting revisions and incorporation of stakeholder feedback within rapid timeframes to support the Safety Net Associate Director and Division Director in regulatory priorities and external affairs.
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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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regulatory affairs jobs Title: intern Company: Medxcel
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