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Depending on specific role, the Associate Director Regulatory Affairs may be involved in various regulatory activities (oversee activities for regulatory submissions; negotiate with regulatory authorities; oversee processes involved with maintaining annual licenses, registrations, ensure external communications meet regulations; lead crisis management program development and implementation; oversee and manage systems related to product safety issues and product recalls, project management, etc.
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QualificationsTo be considered for this role, you’ll require a minimum of 5 years of professional experience in relevant field of healthcare products or related activities e.g.:Work in medical devices industry and/or in vitro diagnostic devices(preferred) or closely related industries (e.g., pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs.
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Assists the Assistant Dean of Student Affairs in determining resource allocation, including budgets and staffing, for student programs, organizations, and events. Essential Duties and Responsibilities: Under the direction of the Assistant Dean for Student Affairs, do the following: A. Guide to Professional Success (GPS) –Scheduling - Oversees and manages GPS CalendarSchedules rooms and appropriate educational technology support for GPS sessions Communication - Manages GPS communication Ensures timely and effective correspondence with session presenters, learning community mentors, and students via email, news board, and student assignments.
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Establish relationships with peers in key functions including MAM, Asset Strategy Leads, Pipeline Commercial Strategy, HEOR, Market Analytics and Insights, US Pricing, International Market Access and US Government Affairs, US Public Affairs, and US Medical Affairs.
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The applicant is expected to develop highly effective collaborations with relevant stakeholders including those in Patient Health & Impact, the Patient-Centered Outcomes Assessment Group, Statistics, Clinical Pharmacology, Clinical Development, Medical Affairs, Epidemiology, Programming, and other groups contributing to HEOR analysis and strategy.
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Engage with regulatory agencies and industry stakeholders regarding regulatory and legislative affairs, including by providing feedback on proposed regulations. 2-5 years' experience working in regulatory compliance or regulatory affairs for a consumer products, food, beverage, cosmetics, or pharmaceutical company, or in a highly regulated industry.
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The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. Title: Regulatory Affairs Specialist II - 5 Openings. 4 years' experience in Regulatory Affairs role.
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The primary focus of this role includes proofreading and light editing for brand communications, public affairs, and business writing. The proofreader will partner with creative directors, project managers, writers, senior designers, and at times, internal Client clientele.
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Cell Therapy functions (CT Manufacturing Operations, Product Operations, Quality Assurance, Quality Control, CT Development, MSAT, Supply Chain, Finance, Regulatory, etc.) Demonstrated leadership & collaboration working in, or closely with, Supply Chain, GMP Manufacturing Operations, Manufacturing Science & Technology, Project & Program management, Quality Assurance / Quality Control Operations and related functions.
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Collaborate with other functions such as project management regulatory formulation manufacturing and quality control in project teams. Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to RD product development design and safety to ensure compliance in all research data collection and reporting activities.
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Job Description Provide EHS project management support on EHS matters including negotiating strategies, technical problem solving, responses to written correspondence & inquiries, compliance inspections and regulatory interpretations.
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Collaborate with scientific support from other CPPM functional groups to provide unified clinical pharmacology position to clinical, CMC & regulatory teams. Act as lead PK scientist in their area of expertise & critically evaluate relevant Clinical Pharmacology, PK/PD & regulatory advances & integrate this knowledge into research or development programs.
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You will report to the Director, Corporate Affairs Operations and will support teams within Corporate Affairs that includes Legal, Ethics and Compliance, Security Loss & Prevention and Environmental Health & Safety.
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The Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.
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Collaborate with internal and external stakeholders to achieve objectives, including but not limited to field sales force, legal, quality, compliance, market access, market insights, finance, regulatory, medical, clinical, scientific, operations, public affairs, executive management, health care professionals, etc.
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regulatory affairs jobs Title: affairs project manager Company: Gpac in North Chicago, IL
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