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The candidate will perform various tasks pertaining to cost accounting compliance for government contracts, including regulatory review and interpretation for current and proposed contracts, preparation of annual cost-related submissions and supporting documentation, ongoing monitoring and review of transactional data for allowability and allocability, and providing support, training and guidance to ensure we comply with applicable regulations.
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The primary role of the Director, Regulatory Affairs - CMC is to create and/or manage contributions from others for CMC regulatory submission documents. This position reports directly to the Senior Director, Head of Regulatory Affairs - CMC. The Director, Regulatory Affairs - CMC will be responsible and accountable for CMC submission documents while successfully up-holding the vision for the function and help mentoring junior team members.
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The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.
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Minimum of 5-7 years’ experience in human subject/clinical research including at least 1-2 years of experience clinical trial monitoring/auditing, research compliance, or regulatory oversight/project management of human subject research protocols.
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The Director of Regulatory Affairs reports to the Executive Director, Regulatory Affairs and will be responsible for developing and delivering global regulatory strategies for product development and approval in alignment with the corporate strategy for Stoke’s portfolio.
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Remain current with regulatory changes to the EAR and ITAR and advise the business and the trade compliance team of the changes as applicable to authorization needs. Description Job Summary:The Licensing Manager, Trade Compliance works with a team of licensing analysts and internal stakeholders to assess international business requirements, prepare export license applications, apply appropriate use of license exceptions when available, and assist business partners to navigate export approvals.
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Works with the City Clerk and the Law Department to coordinate and staff compliance training sessions. Understands and can undertake all of the functions of the City Clerk’s Office including: Vital Records, Elections, Annual Census, Dog Licensing, Business Records, Public Records Law, Open Meeting Law, and Conflict of Interest Law and regulations in order to effectively assist citizens, board and commission members and city staff on the telephone, via e-mail and at the office counter.
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Ten (10) years of experience is required in a legal, regulatory, or compliance position(s) in a life sciences company is required. Essential Functions Works with the General Counsel & Chief Compliance Officer, Trinity’s Compliance Committee and Enterprise Risk Committee to develop and oversee Trinity’s compliance plan and conduct periodic compliance risk assessments and develop responsive action plans to address any identified concerns.
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Director Cyber Security Governance, Risk, & Compliance. Experience with Governance Risk and Compliance technologies and their implementation. Control governance standards will guide enterprise wide IT and business processes on security control requirements to enable business and IT goals and to align with compliance and risk processes.
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Requirements: Master's degree in Regulatory Affairs, Engineering, Life Sciences, or closely related technical discipline (willing to accept foreign education equivalent) and five (5) years of experience as a Regulatory Affairs Specialist or experience executing the complete lifecycle of product registrations before national and international regulatory agencies, including documenting internal processes for quality control, and coordinating post-market surveillance and reporting activities.
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Responsible for the maintenance of regulatory files and tracking databases, including relevant parts of the trial master file. As an integral member of the team that will be tasked with product development, the Associate Director Regulatory Affairs will also serve as a subject matter expert (SME) for assigned development programs, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.
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How you will contribute:EnablingAnalyzes the impact of data and digital regulatory developments on GMSGQ Takeda's business operations and compliance requirements (covering GMS/GQ and the GQ entreprise including but not limited to GQ R&D to LOC quality.
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The Principal Regulatory Specialist is responsible for carrying out Pre-Market and Post-Market regulatory activities in compliance with Digital Factory’s Quality Management System for domestic and various international markets for SaMD products.
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Quality review of regulatory submission projects/ protocol drafts, to ensure studies are conducted in compliance with relevant SOPs and applicable internal, external, regulatory requirements.
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Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products.
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Title: regulatory compliance Company: Flybreeze in Lexington, MA
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