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The Global Regulatory Affairs CMC & Device organization is responsible for global CMC regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch and product lifecycle management.
$209,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. The Global Publishing Manager provides regulatory operations expertise to cross-functional submission project teams, promoting and ensuring excellence in the planning, preparation, and delivery of regulatory submissions.
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Our client is looking to add a Regulatory Compliance Consultant that supports the provision of advisory services to assist financial institution clients to meet legal and regulatory responsibilities, including federal financial consumer protection laws, as well as Bank Secrecy Act/Anti-Money Laundering (BSA/AML) and Office of Foreign Assets Control (OFAC) requirements.
RemoteExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRCMC) will be responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio.
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Minimum of 10 years of experience in global regulatory affairs, with a focus on CMC, in the pharmaceutical or biotechnology industry. Maintain effective communication with internal and external stakeholders to ensure alignment and understanding of CMC regulatory strategies and requirements including change control.
$240,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Pharmacy Postdoctoral Fellow – Medical Affairs Post-Doctoral PharmD Fellowship with Vertex Pharmaceuticals & Northeastern University for 2025-2027 (2 Years). In partnership with Northeastern University, Vertex Pharmaceuticals is offering a two-year Medical Affairs PharmD fellowship based in Boston, MA.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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You will work alongside a small team of ~5-7 other lawyers/paralegals supporting regulatory, corporate, transactional, and procurement matters and closely cooperate with other departments to deliver holistic and streamlined legal support to the U.S. RWE Offshore Wind business.
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An advanced clinical degree (MD, DO, PhD, PharmD) and a minimum of 3 years in medical affairs or a related field. We are looking for a dynamic Director of Medical Affairs with a passion for medical communication and supporting scientific partnerships.
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Demonstrating knowledge of macroeconomic, banking industry and regulatory environment as they relate to financial institutions. A career in our Balance Sheet Management practice, within Financial Risk and Regulatory services, will provide you with the opportunity to help business leaders embed a proactive and dynamic risk management capability and mind set into their corporate business practices.
$256,000 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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Broad experience in US and Global Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways.
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The Client Regulatory Operations & Communications Team is a specialist client-facing team dedicated to our US Mutual Fund/Sub-advisory clients, interacting directly with our clients and collaborating cross-functionally with internal stakeholders to deliver a strong client service experience.
$150,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Providing guidance on FDA approval pathways and regulatory issues under relevant legislation. Partner, FDA Commercialization/Regulatory. With a team of senior business lawyers with substantial in-house and general counsel experience, Outside GC provides private and public companies and non-profit organizations with outstanding corporate and IP legal services as needed at a fraction of the cost of either hiring a full-time general counsel or relying exclusively on law firm counsel.
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15+ years' experience in Regulatory Affairs and Quality Assurance with 10+ years of leadership experience. Provide regulatory leadership and strategic direction to Regulatory Affairs, Clinical Quality, and Medical Writing departments, leading the Regulatory Affairs group, including hiring, mentoring, and leading staff.
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10+ years of relevant regulatory/industry experience in biotech or pharmaceuticals with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization.
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The Associate Director, Regulatory Affairs reports to the Senior Director, Regulatory Affairs and executes clinical and preclinical regulatory strategies and activities.
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Title: regulatory affairs Company: Turnstone Biologics in Waltham, MA
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