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Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$107,659 - $207,763 a yearFull-timeExpandApply NowActive JobUpdated 26 days ago - UpvoteDownvoteShare Job
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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In person or Remote (East Coast with initial training onsite at Bridgewater, NJ and few days for the first few months)DutiesThe CMC Regulatory Technical Writer II authors high quality Module and regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
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Uphold the rules and regulations of Lightbridge Academy and governmental regulatory agencies about children's care, health, and safety. As an early childhood education leader, and a key member of our teaching team, you embody the Lightbridge Academy Core Values and foster a happy and fun learning environment, enhancing the lives of infant, toddler, preschool & pre-k children.
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Prepare/review technical documents including development/tech transfer reports and CMC regulatory submissions. Downstream process development, process optimization, process characterization, and tech transfer.
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Must have completed most of the requirements towards earning the ABA Certified Regulatory Compliance Manager (CRCM) certification). Participate in regulatory compliance examinations performed by the OCC and CFPB. Documents results and presents to management.
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The Senior Statistical Analyst interfaces with key stakeholders (i.e. Statistics, Clinical Data Strategy & Operations, Medical Writing, Regulatory Publishing and Development Operations.) + Fundamental understanding of the drug development process, including experience with regulatory filings.
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Work with R&D scientists, regulatory, commercial, and management teams to provide quick and accurate IP and other legal advice on all aspects of the Hatch-Waxman Act, including the timing of product approvals and launches.
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The Vendor Risk Management Specialist is responsible for supporting Vendor Management's First Line of Defense and Contract Owners / Relationship Managers during vendor due diligence and ongoing monitoring to ensure policy requirements are complete and meet company standards and applicable regulatory requirements.
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This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance. As a Quality and Compliance Team Lead, you will serve as a liaison to key clients, where your leadership and expertise will contribute to the continuous improvement of our drug safety processes, regulatory and contract compliance, and overall patient safety.
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Proven technical capabilities and relevant project experience with management and oversight of cross-disciplinary technical and regulatory specialist teams of other professionals. Coordinate, manage, and direct development of project permitting applications, environmental resource reports, technical study reports and regulatory documents.
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Prepare/review technical documents including development/tech transfer reports and CMC regulatory submissions - Participate on cross-functional teams to progress both early and late stage drug candidates.
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12+ years of relevant compliance and regulatory experience in finance, fintech, or crypto exchanges (experience in AML/BSA compliance is a must) We look for those who possess sound judgment, curiosity, and are able to adapt to a changing regulatory digital asset landscape.
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Collaborate as appropriate with Everest’s Chief Compliance Officer in monitoring and updating compliance policies and procedures governing disclosure requirements worldwide; assist with the design of related compliance training; develop strategies for efficient, effective compliance with legislative and regulatory requirements; and participate in internal investigations as needed.
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regulatory job in Basking Ridge, NJ
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