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Job Title- Senior Manager, CMC Regulatory Affairs, Biologics. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
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Liaise with colleagues in Regulatory Affairs therapeutics teams, Gilead local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
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Experience representing CMC regulatory affairs on regulatory and cross functional teams. Top 3 Required Skill Sets: Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions.
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Your role will encompass identifying innovative opportunities within the digital health landscape, ensuring regulatory compliance, and crafting digital experience strategies that enhance satisfaction, loyalty, and advocacy.
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Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsDuration: months (we would like to start with months, with the potential to extend if the person is highly competent and a good resource for our team)Location: Remote but preference is to have a candidate available to be onsite at the Foster City, CA offices - days if possible RESPONSIBILITIES MAY INCLUDE.
$90 - $101.35ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing strategic direction, operational support, and technical expertise for. Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC Regulatory activities and initiatives.
$199,320 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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E.g., CDISC, SDTM, ADaM) and ensure that data models and analytics adhere to regulatory and operational guidelines. clinical trial processes , operational workflows, and regulatory requirements (FDA, EMA, ICH GCP.
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This investigation includes but is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent). Certifications: Series 07 - FINRA, Series 63 - FINRA, Series 65 - FINRA, Series 66 - FINRA Company Overview Fidelity Investments is a privately held company with a mission to strengthen the financial well-being of our clients.
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You will work across multiple frameworks and regulatory standards including, but not limited to, NIST CSF, ISO, GDPR, SOX, PCI, FedRamp, SOC2 etc. Rubrik is investing in these areas to address the evolving cybersecurity threat landscape, as well as regulatory compliance requirements as the company continues to grow.
$259,600Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We are looking for an experienced and innovative credit attorney to join our product and regulatory counsel team as Senior Counsel, reporting to the Deputy General Counsel and VP, Regulatory & Product at Robinhood.
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Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
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The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.
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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.
$165,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We assist companies and non-profit organizations in delivering benefits to their employees. Certifications:Series 07 - FINRA, Series 63 - FINRA, Series 66 - FINRA. We welcome those with experience in jobs such as Payroll Specialist, Bilingual Customer Service , and Senior Accountant and others in the Accounting and Finance to apply.
$75,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Author/review and/or coach team members to author CMC regulatory sections of IND/INDa. Contribute to regulatory strategies and support associated agency interactions and product-related inspections.
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regulatory job Title: pharmacy tech Company: Abrazo Health in Redwood City, CA
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