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Works closely with the Head of Regulatory Affairs to drive business planning, ensure strategic and operational alignment across sub functions, and to deliver on business transformation part of Alexion's integration with AstraZeneca, with a specific focus on R&D. This role will also be responsible for proactively supporting the Alexion Regulatory Affairs organization development and strategy, along with supporting key initiatives, meetings, and messages.
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In close partnership with Clinical R&D business process owners, sponsors & stakeholders including Clinical Science & Operations, Data Management & Biostatistics, Regulatory Affairs, PV, Biometrics, & Clinical Quality, provide leadership & subject matter expertise to drive timely & compliant planning, evaluation, procurement, implementation & operation of Clinical R&D systems.
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Cross-functional Collaboration & Influence: Work closely and exert influence across Operations, HEOR, Medical Affairs, Regulatory Affairs, and Brand Teams to align global strategies with regional and local needs, maintaining hands-on involvement in strategic initiatives to ensure effective delivery and execution.
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An exciting and innovative clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer and autoimmune disease is looking for an Executive Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization.
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If you are an inclusive leader with a strong background in regulatory affairs, strategic planning or sustainability, and you are looking for a challenging and rewarding career that can make a positive difference in the world, this is the opportunity for you.
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Oversee compliance with Equal Employment Opportunity laws, Title IX compliance, Clery Act, and Student Conduct and Discipline, including strategic planning, education, awareness, and prevention programs.
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Senior Director, Business Planning & Operations, Regulatory Affairs. The (Senior) Director, Business Planning & Operations, is responsible for managing business processes in the Alexion Regulatory Affairs team and is a member of the Alexion Regulatory Affairs Leadership Team (RALT.
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The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.
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The position has oversight of strategic planning, fiscal affairs, staffing, fundraising and promotions, athletics facilities, regulatory compliance concerning Intercollegiate athletics, and general operations.
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Coordinate product/strategy implementation by working with cross-functional teams, including Engineering, Marketing Communications, Compliance, Legal, Regulatory Affairs, Medical Education, Sales Training, etc.
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The Associate Director, Clinical Supply Chain will play a pivotal role in overseeing the strategic planning and execution of clinical supply chain operations. Collaborating closely with cross-functional teams including Clinical Operations, Manufacturing, Quality Assurance, and Regulatory Affairs to forecast demand, plan supply needs, and coordinate distribution activities.
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Provides direction and input to all in-house groups to include Global Marketing, Finance, Public Affairs, Scientific Affairs, Training, and Regulatory that affect the successful achievement of business objectives.
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Our Medical function serves as a key strategic partner with commercial, regulatory, clinical, and market access on therapeutic solutions to support patients’ needs. Main responsibilities:The Global Medical Director of the Dermatology, Atopic Dermatitis reports to the Global Medical Head of Immunology and works under the direction of the Dermatology and Rheumatology Global Medical Lead. This role will closely collaborate with cross-functional teams, develop, and execute asset medical plans, support lifecycle management activities, and integrate evidence-generation planning.
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The Associate Director, Regulatory Affairs, Strategic Global Labeling Combination Products and Devices, combines the knowledge of scientific, regulatory, and business issues to support labeling for products that are developed, manufactured or distributed to meet required legislation.
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Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety and Epidemiology (e.g., product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing.
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strategic planning regulatory affairs jobs Title: director
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