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Japan Regulatory Strategy Group Senior Manager

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Lead regulatory strategy for drug development and approvals in Japan. This senior manager role requires 10+ years Regulatory Affairs experience, native Japanese, and strong English skills. You will develop submissions, interface with authorities, and guide cross-functional teams in Tokyo.
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Japan , Tokyo
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Not provided
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Business Performance Senior Manager

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Lead Regulatory integration for mergers and acquisitions at a senior level. This Hyderabad-based role requires deep expertise in the regulatory lifecycle and drug development. You will drive strategic solutions and process improvements within a global team. A scientific degree and 10+ years of di...
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India , Hyderabad
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Not provided
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Until further notice

Senior Associate Data Management

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Join Amgen as a Senior Associate, Data Management in Hyderabad. You will lead key regulatory initiatives in Veeva RIM Vault, ensuring compliance with IDMP and EU CTR. Your role involves managing data, implementing processes, and training global teams. We seek a Veeva SME with strong analytical sk...
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India , Hyderabad
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Not provided
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Associate Director Regulatory Affairs

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Lead a high-impact CMC & Device Regulatory team in Hyderabad, India. This senior leadership role requires a doctorate/master's with 12+/14+ years of CMC/Device regulatory experience and 5+ years leading teams. You will drive strategic oversight, global submissions, and foster an inclusive culture...
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India , Hyderabad
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Not provided
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Material Compliance Manager

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Lead material compliance initiatives for a global biotech leader. Manage the promotional review process, ensuring regulatory adherence and stakeholder alignment. Utilize your expertise in process management and cross-functional collaboration. Enjoy a competitive benefits package with bonus potent...
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Location
United States
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Salary
112061.00 - 139899.00 USD / Year
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Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

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Lead global regulatory strategy for late-stage obesity therapeutics at Amgen. This senior director role requires extensive regulatory experience in biotech or science, from development through submission and lifecycle management. You will guide cross-functional teams to achieve worldwide approval...
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United States
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220356.00 - 269853.00 USD / Year
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Regulatory Writing Senior Manager

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Lead complex regulatory submissions as a Senior Manager, leveraging your 5+ years of pharmaceutical medical writing experience. Author and oversee key documents for new drug applications, serving as the functional lead on product teams. This US-based role offers a comprehensive benefits package, ...
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United States
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152684.00 - 193308.00 USD / Year
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Associate Director Biostatistics

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Lead biostatistical strategy and execution for global clinical programs at Amgen's India center in Hyderabad. This senior role requires a PhD with 12+ years (or MS with 16+ years) of pharmaceutical industry experience. You will provide scientific leadership, oversee trials, and mentor teams while...
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India , Hyderabad
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Not provided
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Senior Manager Biostatistics

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Lead study-level statistical deliverables as a Senior Manager in Hyderabad. Utilize your PhD/Master's and 8-12+ years of pharma industry experience to guide clinical development and ensure regulatory quality. Manage a team, mentor staff, and grow within Amgen's inclusive global organization offer...
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India , Hyderabad
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Scientist – Research Computational Biology

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Join Amgen's ARIA Computational Biology team in Hyderabad. Apply your computational biology and data science expertise to discover transformative therapeutic targets. Analyze multi-modal omics data, develop advanced methods, and collaborate cross-functionally. A PhD or Master's with strong Python...
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India , Hyderabad
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Scientific Associate Director - Pharmacokinetics and Drug Metabolism

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Lead a PKDM team in Hyderabad, supporting small molecule drug discovery. Utilize your 12+ years of industry experience in ADME/PK to drive project progression and strategy. This role involves overseeing in vitro/in vivo studies and mentoring scientists in a new research facility.
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India , Hyderabad
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Not provided
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Principal Scientist – Synthetic Separations

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Lead analytical strategy for drug discovery at Amgen's Genome Valley facility in Hyderabad. Utilize deep expertise in LC/MS, SFC, and NMR to characterize novel compounds. This senior role requires a PhD with 8+ years' industry experience and leadership in synthetic separations.
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Location
India , Hyderabad
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Not provided
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