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You will be responsible for providing, scientific leadership, and collaborative working environment to advance the drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders including in vitro & In vivo pharmacology, clinical biomarkers, DMPK, clinical development and operations, regulatory, CMC, and medical affairs.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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This position will interface with Sanofi-Genzyme leadership, Regeneron alliance partners, Sanofi Digital Accelerator, IT, Field Commercial and Medical Leadership, Regulatory, Medical Affairs, Business Operations & Strategy, and Product Communications.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Thorough understanding of the cross functional drug development processes (Clinical Operations, Biometrics, and Regulatory Affairs) and GCP. Collaborate with Pharmacovigilance, Medical Affairs, CMC and applicable functional specialists to identify, evaluate and manage safety signals including input in Health Hazard Assessments.
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Job Category: Legal/Regulatory/External Affairs. Employees in this role directly support management and development through representation of our company’s interests in regulatory bodies, regional transmission, and planning organizations and legislatures and members of the executive branch of state governments in the United States and provinces in Canada.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Director, Federal Regulatory Affairs will report to the Managing Director, Federal Regulatory Affairs and will provide centralized management of Constellation’s advocacy at the Federal Energy Regulatory Commission (FERC) and other organizations, as appropriate, including all communications with FERC, internal development of positions, participation in proceedings, preparation and filing of pleadings, and informal advocacy.
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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.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The purpose of the Sr. Director role in Global Regulatory Affairs (GRA) – Drug Delivery and Digital Health provides strategic, tactical, and operational direction to expedite Lilly’s drug/device combination products in development.
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With a focus on clinical products, the Sr. Director is expected to contribute to the overall business strategy, clinical direction and culture of the organization, working closely with other functions within BD Bioscience, including regulatory affairs, quality, R&D, marketing and commercial functions.
$208,600 - $375,500 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Sr. Director of Regulatory Operations, Business Systems is a member of the Regulatory Operations expanded team within BridgeBio and works in a hands-on capacity to support projects through new product development and commercialization.
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Just-Evotec Biologics is seeking a Director/Sr. Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing.
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Coordinate drug supply delivery timelines with Clinical and CMC; Packaging, Labeling, and Distribution CRO's; and indirectly with GMP manufacturers, QA, and Regulatory Affairs, Provide interpretation of regulatory guidance documents, regulations and directives and advising regarding their applicability and impact on internal labeling programs.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Work with colleagues in CMC, QA, commercial, clinical, and regulatory affairs to ensure appropriate selection and oversight of vendors. Director/Sr. Director, Supply Chain and Procurement.
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Set the objectives, priorities and goals of the organization and ensure KPI attainment is achieved; Evolve operations, optimizing enablement and build engagement analytics that will demonstrate transparency and foster trust; Integrate cross-functional perspectives (Pre-Clinical, Regulatory Affairs, Clinical Development, Medical Affairs, Patient Safety, Pharmacovigilance, M&A) into strategic assessments and recommendations.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs. Plan and conduct clinical trialsDeliver high-quality results within established timelinesDemonstrated track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
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Advanced degree in a scientific or related discipline with substantial experience in regulatory affairs, specifically CMC documentation for biotech or pharmaceutical products. Collaborate with cross-functional teams within CMC and Regulatory Affairs to harmonize documentation practices with global regulatory strategies and submissions.
ExpandApply NowActive JobUpdated 11 days ago
regulatory affairs jobs Title: sr director
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