Regulatory Affairs Jobs in Cambridge
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Search Results - Regulatory Affairs Jobs in Cambridge
Regulatory Jobs-Cambridge
Director, Regulatory Affairs, Global Labeling Strategy (US)
Overview
The Director of Global Labeling (GL) US will play a lead role in building and refining Alnylam’s global labeling strategy processes and capabilities; supervise junior labeling...
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Green Key Resources-Cambridge
Overview
In this role, you drive advertising and promotional compliance for pharmaceutical products and provide strategic regulatory guidance for product communications. You will partner with Marketing, Legal, and Medical Affairs to ensure...
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AbbVie-Cambridge
opportunities, 3) formulating recommendations and development scenarios related to Regulatory Affairs aspects for executive management consideration, and 4) participating in negotiations and ensuring timely execution of legal agreements with external parties...
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Baxter International-Cambridge
Overview
Senior Regulatory Affairs leader responsible for developing and executing regulatory strategies to enable timely market access and ongoing compliance across international markets, with strong US FDA expertise. You will coordinate cross...
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Editas Medicine-Cambridge
The Role:
The Vice President, Regulatory Affairs will lead and build the global regulatory function and strategy for a growing portfolio of in vivo gene editing therapies, serving as the company’s primary regulatory expert and strategic advisor...
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Takeda-Cambridge
Overview
In this role you lead and execute regulatory CMC strategies for Takeda’s products within GRA CMC, interfacing with cross-functional teams and Health Authorities. You drive regulatory submissions, ensure global compliance, and mentor team...
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Editas Medicine-Cambridge
The Vice President, Regulatory Affairs will lead and build the global regulatory function and strategy for a growing portfolio of in vivo gene editing therapies, serving as the company’s primary regulatory expert and strategic advisor to executive leadership, program...
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Regulatory Jobs-Cambridge
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Job Description:
The Vice President, Head of Global Regulatory Operations provides enterprise leadership for Regulatory Operations across Global Regulatory Affairs (GRA), defining the long-term vision...
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ZOLL Medical Corporation-Cambridge
and own PLM processes, driving data integrity, traceability, and change control. You’ll shape the PLM strategy with Engineering, Quality, Regulatory Affairs, Manufacturing, and IT, ensuring alignment with regulatory requirements.
This role offers impact...
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Regulatory Jobs-Cambridge
Alnylam seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead the US labeling function and shape global labeling processes. You will supervise labeling strategists and guide CCDS, CPI, and TLP development for investigational...
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Scholar Rock-Cambridge
of Position:
The Vice President, Head of Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is accountable for building and leading the Global Regulatory Strategy team, responsible for the development of global regulatory strategy...
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AstraZeneca-Cambridge
safety strategy and communicate safety information to stakeholders.
In a global, cross-functional environment, you will collaborate across Clinical Development, Regulatory Affairs, Safety Science, Medical Affairs to protect patient safety and support
#J...
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Deciphera Pharmaceuticals-Cambridge
Overview
In this role you will lead global clinical supply planning and execution to ensure uninterrupted investigational product availability. You will partner across Clinical Operations, CMC, QA, Regulatory Affairs, and external vendors...
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Scholar Rock-Cambridge
regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission...
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Eliassen Group-Cambridge
regulatory evolution, and advocacy.
• Lead coordination across Clinical Development, Regulatory Affairs, Medical and Patient Engagement, Market Access and Commercial, and CMC/Supply to ensure accountability and milestone delivery.
• Prepare the DASP and lead...
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