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In collaboration with the Clinical Affairs Lead and Medical/Scientific Lead, prepares strategy decisions, presents, and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
$269,400 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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This includes the management and preparation of various critical regulatory documents such as: product Safety Data Sheets, product labels, product attestation documents and certifications. Required Knowledge: Regulatory, Scientific/Technical, QA, Business acumen.
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Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.
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You will lead a program focused on managing third party providers, import duty expense, customs classification, maintaining good standing and participation in programs with U.S. Customs and Border Protection, ensuring all U.S. and Canadian import compliance regulatory requirements are met and fostering a culture of integrity and ethical conduct throughout the organization.
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Collaborate effectively in a matrixed environment with Medical Affairs, Creative/CRM/Digital agencies, Media, Market Research, Analytics, Business Technology Solutions (BTS), Field Operations, and Medical/Regulatory/Compliance/Legal integrated business partners.
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This position is ideal for self-starters with bank auditor experience, regulatory examiner experience or banking industry experience within risk management. Audit experience within Banking, Accounting / Consulting, Regulatory Agencies, or Financial InstitutionsCertified Internal Auditor (CIA) or willing to obtainAdditional Certifications:CRCM, CPA.
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This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.
$225,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Partner across functions to ensure robust systems in place to meet regulatory and stakeholder expectations in the areas of environmental compliance, product compliance, supplier conduct, and sustainability/ESG; support response to internal and external stakeholder information requests in these areas.
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QUALIFICATIONSEducationBachelors Degree (± 16 years)In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields are preferred or an equivalent combination of education and work experienceMasters Degree (± 18 years)PreferredDoctorate Degree (± 19 years) PreferredExperience/BackgroundMinimum 10 years Progressive work experience in regulatory affairs or a related discipline in the medical device field.
$324,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Your teamAs a Principal Engineer at Baxter, you will provide Sterility Assurance leadership and technical support to multi-disciplinary product development teams, domestic/international manufacturing facilities, Regulatory Affairs and internal Sterility Assurance customers.
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Drives small teams with members from Pharmacometrics functional groups to provide a unified modeling and simulation position to clinical, CMC and regulatory teams. Anticipates and critically evaluates Statistical, PK/PD, Clinical Pharmacology, or regulatory advances, strengths, weaknesses, opportunities and threats, and responds with appropriate new strategies.
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Combination of education and experience where I have successfully completed a community planning degree, or a degree in a related discipline such as urban affairs, architecture, landscape architecture, engineering, sociology, geography, economics, political science, or public administration and have one (1) year of work experience in community planning acquired under the supervision and guidance of a community planner.
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The Senior Mental Health Clinician serves as a supervisor to all Mental Health Clinicians by providing on-going training, coaching and supervision to ensure effective and successful service delivery in compliance with regulatory.
$90,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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At the FBI you will have the opportunity to channel your knowledge of criminal law, constitutional law, or regulatory compliance to impact public corruption, organized crime, civil rights, and more.
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General Functions, Specific Responsibilities, and Authority:The Senior Quality Engineer works closely with shared functions (e.g. Regulatory Affairs, Designated Complaint Handling Unit (DCHU), Sterility Assurance, etc.
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regulatory affairs jobs Title: sr regulatory affairs associate Company: Modis in Libertyville, IL
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