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Support development of CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks. Provides CMC regulatory guidance to manufacturing and quality teams; evaluates CMC change controls.
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In this role, you will lead the legal support, including directly advising, educating BMS colleagues, staying current on evolving global regulatory, legal and policy environment for BMS’ work with digital solutions, including regulated patient and physician-facing digital health solutions (e.g., digital medicine and digital therapeutics) such as mobile applications, diagnostic algorithms, digital biomarkers, use of artificial intelligence and clinical decision support solutions.
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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
$142,500 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations. Minimum of 10 years of pharmaceutical industry experience, at 8+ years in Regulatory Affairs with emphasis on CMC. Must have managerial experience.
$80,000 - $170,000 a yearFull-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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A Sr. TLL will work closely, and within approved SOPs, with other field professionals, including but not limited to ZBDs (Zone Business Directors), RBDs (Regional Business Directors), ABMs (Area Business Managers) in addition to home office-based colleagues in Marketing, Medical Affairs, Sales, and Market Access.
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Business partner to R&D, regulatory affairs, and business development teams on product development and drug approval pathways, and on R&D and commercial issues. The Senior Director, Head of Regulatory Law reporting to the VP, General Counsel will provide regulatory counsel to the Rx, Generic, and OTC business at Sun Pharmaceuticals, and its affiliates including Taro Pharmaceuticals.
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Maintain effective and appropriate communication among internal stakeholders (Medical Affairs colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory requirements.
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Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) 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 Academic Affairs Program Associate reports to and supports the Vice Provost for Academic Affairs and also supports the Assistant Provost for Academic Studies and Analysis. The Academic Affairs Program Associate contributes to the work of Academic Affairs in the Office of the Provost by supporting the committees, special projects, and routine responsibilities of this unit.
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Collaborating with Medical Affairs colleagues and external vendors to execute asset strategy and tactical plans with appropriate use of resources and according to developed timelines. 10+ years experience in pharmaceutical industry Medical Affairs specifically.
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The Vice President of Global Strategic Regulatory Operations (GRSO) reports directly to the Senior Vice President of Global Regulatory Safety and Biometrics (GRSB) and is a member of the GRSB Leadership Team. As such, this position has accountabilities for the sustained health, growth and continuous improvement of the GRSB organization, inclusive of developing effective partnerships with critical stakeholders across the BMS enterprise.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs activities and services are fully compliant with Ascendis SOPs and US as well as global regulatory and compliance rules/law.
$350,000 - $400,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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S/he will work cross-functionally with other leaders and functions (including all Medical Affairs functions, Commercial, Compliance, IT, Finance, Clinical Development and Legal) to drive from inception to completion all Rare Disease MA workstreams and projects and to provide relevant medical input on the strategic and tactical support for DAYBUE (trofinetide) in the US and in OUS markets.
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Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance and Quality, related aspects and their intersection with Regulatory Affairs. Location: Hybrid (2 days a week in Princeton, NJ office) The Executive Director, Head of Regulatory Affairs position will provide regulatory expertise and leadership to ensure that the company meets its objectives.
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They will coordinate with other TA functions including Medical Directors, Alignment Director, Program Development Director and the Medical Liaison field team both within TA and across other TAs. This position will also coordinate with key functions across CMR (eg NACO), Public and Government Affairs and commercial.
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Title: regulatory affairs Company: Sanofi in Lawrence, NJ
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