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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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Requires successful track record of at least 10 years of experience providing legal advice on relevant areas of the law (e.g., corporate, privacy, health care regulatory, litigation, contracts, et al) at a top law firm or in-house corporate law department.
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For the health and safety of our team members and residents, Oakmont Management Group may require team members to vaccinate, participate in daily screening, surveillance testing, and to wear face coverings and other personal protective equipment (PPE) to prevent the spread of the COVID-19 or other communicable diseases, per regulatory guidelines.
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A bachelor's degree with a minimum of 2 years of experience in food regulatory or Master’s degree in food science. Collaborate with the Import Team, Purchasing team, and vendors to address regulatory and product issues.
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Technical documents such as tech transfer protocols and reports, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs. Present during inspections from regulatory agencies and client audits.
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We are seeking a Principal Regulatory Affairs Specialist to join Abbott's Heart Failure Division on-site in Pleasanton, CA. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment.
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The ideal candidate will have a proven track record for developing optimal renewable energy supply solutions by creatively leveraging their skills and significant experience across a spectrum of renewable energy supply issues including project development, finance, commercial, regulatory, market, technical, legal, and tax.
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Basic knowledge of industry and regulatory standards, design criteria and codes relevant to Instrumentation and Controls. Intermediate knowledge with PLC programming: Rockwell RSLogix 5000 (required), Allen Bradley, Delta V, Siemens, Exposure to multiple PLC manufactures and platforms.
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Ensuring regulatory/trade compliance, risk mitigation of supply chain disruptions and adherence to safety regulations and SOPs (including IATA, IMDG, Import/Export trade compliance and local regulatory requirements based upon chemicals in inventory.
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Provides reports for external, regulatory audits such as those required by CMS, UNOS, AATB, and processors. With guidance from the Director of Learning and Development (L&D), the LMS Administrator III supports operations of the learning management system, maintains training records, coordinates training assignments, delivers customer service, and fosters continuous improvement by actively participating in the Quality Assurance Performance Improvement (QAPI) program.
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Contribute to the development of Snowflake's ESG program and help prepare for ESG regulatory compliance and sustainability reporting (e.g., SEC, California, and CSRD disclosure requirements) 3-5 years of professional experience, ideally focusing on compliance matters such as DOJ compliance programs or anti-corruption.
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Participates in the GRC governance process to assist in updating and reviewing credit union policies and procedures based on regulatory changes, internal audits, and examinations by regulatory agencies.
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Manage assigned projects from inception to completion, ensuring that all activities, including contracting, RF design, product/equipment ordering, permitting regulatory, construction, optimization, site acquisition, close-out, and hand-off to ops are effectively and efficiently coordinated and completed on time within budget and in accordance with the underlying contract / LSO.
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Ensure that all study-related documents are accurate, complete, timely and filed appropriately in all clinical (Veeva TMF), regulatory, safety and finance systems. Team leader and builder, who manages trial deliverables, timelines in assigned protocols to meet country commitments and regulatory requirements.
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A “disabled veteran” is one of the following:a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
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regulatory affairs jobs Title: regulatory affairs Company: Beigene in Pleasanton, CA
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