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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
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As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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Communicate frequently with other Respiratory Sales Specialists across the country and cross-functional counterparts such as Marketing, Sales Ops, Market Access, Field Reimbursement, Training, and Medical Affairs to create alignment of business plan, focus on strategic drivers, and sharing best practices.
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The Medical Science Liaison (MSL) is a member of a field-based team who function as an extension of the US Medical Affairs organization. MSLs provide medical information through scientific exchange in a fair- balanced manner and provide clinical/scientific support for Bristol Myers Squibb and the Medical Affairs department at the direction of Medical Affairs management.
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The FRM will need to coordinate cross functionally within Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, and Specialty Pharmacy Account Management.
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Full Knowledge of the drug development, study conduct processes, regulations related to Data Management and clinical research such as CFR Title 21, ICH Guidelines, EU Directives, GCP and relevant regulatory compliance.
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The Internal Audit Control Manager - Compliance Subject Matter expert is primarily accountable for ensuring adequate and appropriate audit coverage of federal/state/GSE requirements applicable to the organization by maintaining the compliance matrix and providing input to the audit plan and advice to audit teams regarding consumer compliance regulatory applicability.
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In compliance with legal and regulatory requirements, the MSO will also lead when appropriate, in the design and implementation of risk mitigation strategies to ensure the safe and appropriate use of Janssen products.
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Manager - Regulatory Affairs CMC page is loaded. Manager - Regulatory Affairs CMC. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies.
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Licensed Speech Language Pathologist, State of New Jersey Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech Pathology Advisory Committee pursuant to NJSA and NJCA. This includes a temporary license as approved by the NJ DOH personnel standards for early intervention personnel.
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Rider University invites applications for the position of Director of Sponsored Programs and Research within the Division of Academic Affairs. The Director will collaborate with the Grants Account Manager in Finance to ensure that appropriate financial reporting is submitted promptly.
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GPAC is a national recruiting and professional placement firm- applying for this job may qualify you for other positions available as well. GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States since 1990.
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ERM delivers a wide range of climate change services including decarbonization strategy development, creation of Scope 1, 2, and 3 carbon inventories, Task Force on Climate-related Financial Disclosure (TCFD) analysis and reporting, strategy development, policy and regulatory analysis, target setting, and benchmarking.
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Assist in the preparation of budgets, forecasts, ALCO reporting, and regulatory reporting. Participate in financial and operational audits and regulatory exams. Interact with various teams on project initiatives and accounting-related items.
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If you would like to learn more about Manufacturing opportunities, contact Dan Poel with gpac. Strong theoretical background with practical experience in circuit board design, schematic generation, and PCB layout tools such as Orcad/Altium.
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regulatory affairs jobs Title: regulatory project manager Company: Gpac in Trenton, NJ
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