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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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Regularly interfaces with team members in R&D including Biostatistics and SAS Programming staff, Data Management, clinical research and operations teams, regulatory affairs, clinical pharmacology, medical writing, medical affairs and quality management.
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Support project teams, regulatory affairs, product management, marketing, and product stewardship in topics related to toxicology and kinetics. The position is located in Princeton, NJ and is part of the global Regulatory Affairs Toxicology Group.
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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.
$165,200 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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As Senior Regulatory Affairs Manager, Pharma within the North America region, you will be part of a cross-functional team, based in Plainsboro, NJ. The activities linked to the position are highly complex due to the dynamics of the North American market and changing regulatory environments.
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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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Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred) As a key member of the Regulatory Affairs leadership team, you will play a critical role in ensuring compliance with global regulations and driving the growth of our company.
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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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Importantly, the chosen candidate will manage and mentor a group of Regulatory Affairs strategists. Genmab is looking for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.
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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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Lead the launch planning process for APOC’s game-changing TBI test; define regulatory, market access, pricing, distribution, sales force organization and promotion strategies and develop sales forecasts.
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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.
$97,000 a yearInternExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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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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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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac in Ewing, NJ
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