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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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The Director of Federal Government Affairs represents the organization’s policy and regulatory positions to elected representatives and their staff, as well as to officials and staff in the executive branch and other agencies.
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Work closely with State & Local Government Affairs and Regulatory Affairs on multi-tiered strategy that crosses our state footprint and at the federal level. Work closely with the federal affairs and regulatory affairs and policy teams on ongoing engagement of key legislative activity, including bill analysis and tracking; attending hearings, briefings and mark ups; and general legislative monitoring.
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The Director of Federal Government Affairs involves direct engagement with Senate, House, and/or Administration officials and staff on a variety of issue areas central to FirstEnergy. Minimum of 12-15 of professional experience in Senate, House, Administration, government affairs, campaign, energy policy and/or advocacy roles.
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This position will receive continuous guidance and mentoring by the Director of Regulatory Affairs and/or the Deputy Chief Regulatory Officer and the Chief Regulatory Officer, as applicable.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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The UPSIDE Foods Global Scientific & Regulatory Affairs (GSRA) team is hiring an Associate Director, Regulatory Operations to proactively create and build effective regulatory compliance operational capabilities.
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Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD, or MD preferred) Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA) A broad knowledge of development and life-cycle management is preferred.
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Director, Regulatory Affairs @ Half Magic Beauty. Minimum 8-10 years of combined regulatory affairs experience in color cosmetics, both in domestic and international markets.
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The successful candidate will work collaboratively with the dynamic Federal Legislative Affairs team, as well as regulatory and business teams, to develop policy positions, formulate lobbying strategies, and coordinate Hill outreach to drive desired outcomes on critical issues.
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Director, Regulatory Affairs Strategy page is loaded. Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred.
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OPPORTUNITY Mammoth is hiring a Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market.
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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
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Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) Importantly, the chosen candidate will manage and mentor a group of Regulatory Affairs strategists.
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Head Therapeutics Counsel and will be responsible for providing legal support to business partners in various departments across the organization, such as Disease Strategy Teams, Global and North America Marketing, North America Sales, Patient Advocacy, Patient Support, Health Economics And Outcomes Research, Global Medicines Development and Medical Affairs (GMDA), Field Training, Market Research, Business Analytics, Regulatory Affairs, Public Affairs, and Corporate Communications.
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regulatory affairs jobs Title: director clinical assoc in Troy, New York
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