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This role is crucial in ensuring that all CMC aspects of drug development meet regulatory requirements globally, supporting Scorpion Therapeutics' mission to bring transformative oncology therapies to patients.
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Executing model risk management activities and projects consistent with the Enterprise MRM framework, industry best-practice and regulatory guidance. The incumbent is also responsible for addressing and executing model risk management activities consistent with framework, best-practice and regulatory guidance.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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Develop and execute a comprehensive third-party risk management strategy aligned with organizational objectives, regulatory requirements, and industry best practices. Collaborate with internal stakeholders including IT, legal, compliance, procurement, and senior leadership to integrate third-party risk management and information security into business processes.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs. Coordinate/author/review drug substance relevant sections of regulatory documents (IND, IMPD, NDA and MAA.
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The Senior Research Regulatory Coordinator (RC) works under the direction of the CCI Executive Director, Research Operations Director, and Principal Investigator(s) to complete the regulatory requirements of clinical research projects.
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In addition, the work often includes historical research, filing the proposed work with regulatory agencies (LPC, SHPO, NPS, etc.) A valid driver’s license and willingness to travel throughout New England is essential, as work of this office includes projects throughout the region.
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Extensive experience of industry standards, codes, and regulations related to structural design and construction (e.g., ACI, AISC, ASCE, FEMA, FERC, U.S. Army Corps of Engineer structural and regulatory compliance.
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Ensures compliance within guidelines set forth by regulatory agencies (DPH, ERISA etc.) Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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Handle initial determinations, appeals and grievances within the scope of expertise as defined by MassHealth, Medicare, NCQA and the Division of Insurance and within the compliance requirements of key regulatory and accreditation entities.
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The Corporate Counsel will also assist in providing legal services on a variety of other matters, including commercial contracts, corporate governance, regulatory matters, intellectual property, dispute resolution, litigation, and other projects and initiatives.
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Collaborate with cross-functional teams, including analytical development, process development, quality assurance, and regulatory affairs, to ensure seamless project progression. Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
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Investigate and document reports of non-compliance involving laboratory animal care and use, including preparation and submission of reports and other documents to the IACUC, IO, and regulatory and accrediting agencies when indicated.
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Manage CRO interactions for timely DMPK study execution; support regulatory document preparation and presentation/publication strategies. Strong understanding of PK/ADME assays, methods, and models, as well as expertise in managing CROs and knowledge of regulatory guidance’s.
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Working knowledge of the Risk Management Framework (RMF) concepts and policies across risk types (regulatory, financial crimes, credit, operational, etc.) Knowledge and understanding of technology regulatory guidance and industry frameworks or standards FFIEC, NIST, ISO, COBIT, PCI, ITIL, SOX, SOC.
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regulatory job Title: travel Company: Next Move in Boston, MA
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