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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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The CMC Regulatory Affairs position holds a crucial role within the organization, overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory affairs for pharmaceutical products.
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Two (2) years of progressively responsible experience in regulatory affairs, legislative affairs, or energy policy at an electric utility, regulatory agency, or legislative office.
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D., Masters and Ph. D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology- RAC certification a plusExperience:- 7 years or more of CMC regulatory experience in the pharmaceutical industry with a history of successful of investigational filings and approvals of marketing applications as the CMC Regulatory lead.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.Demonstrated organizational leadership skills at both functional and enterprise levels.
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The Policy Advisor works under the direction of the Manager of Energy Policy, representing Central Coast Community Energy in various regulatory and compliance matters. Regulatory bodies will generally include the California Public Utilities Commission, the California Independent System Operator, and the California Energy Commission.
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The Wounded Warrior Project (WWP) Government Affairs Deputy Director assists in the development and implementation of WWP’s public policy strategy to advance its legislative, regulatory, and advocacy priorities.
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The Director of Regulatory Affairs and Customer Compliance is responsible for overseeing and providing leadership for all regulatory and export compliance matters within the MFI Integrated Supply Chain.
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Familiarity with the AML/CFT and sanctions regulatory environment for digital assets globally, including the BSA, OFAC and other sanctions regulations, and travel rule requirements. 12+ years of combined in-house/Biglaw experience, including leading regulatory coverage, preferably in fintech, banking, payments, capital markets or other institutional financial services.
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The Army public affairs specialist participates in and assists with the supervision and administration of Army public affairs programs primarily through news releases, newspaper articles, Web-based material and photographs for use in military and civilian news media.
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The person in this role specifically interacts with the Faculty Directors of McCourt academic programs, the Associate Dean of Student Affairs, McCourt Communications and Events staff, student organization leaders, and numerous student resources at Georgetown as they support McCourt students and the Office of Student Affairs suite.
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The Director will chair the respective neurology TA Global Publications Team as well as engage with cross-functional partners including but not limited to research, clinical development, marketing, market access, medical affairs, regulatory affairs and biostats.
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This incumbent serves as a key member of the site leadership team, and will interact routinely with Manufacturing Management, Operations, R&D, Sales and Marketing, as well as Corporate Quality and Regulatory Affairs.
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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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regulatory affairs jobs Company: Maximus
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