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Principal Regulatory Affairs Specialist
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Philips Cambridge, United States**Job Title**: Principal Regulatory Affairs Specialist · **Principal Regulatory Affairs Specialist · - Software & Artificial Intelligence (U.S. Hub Based)** · The Principal Regulatory Affairs Specialist · - SW & AI will shape, lead and execute innovative regulatory strategies to ...
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Lead Regulatory Affairs Director
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Manager, Regulatory Affairs
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Manager Regulatory Affairs
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Manager, Regulatory Affairs
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Director of Regulatory Affairs
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Manager, Regulatory Affairs
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Deciphera Pharmaceuticals Waltham, United StatesJob Description · Job DescriptionCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhib ...
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Director of Regulatory Affairs
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Director, Regulatory Affairs
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Regulatory Affairs Director
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VP, Regulatory Affairs
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Vigil Neuroscience Watertown, United StatesVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of mo ...
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VP, Regulatory Affairs
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Vigil Neuroscience Watertown, United StatesVigil Neuroscience is the worlds first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brains immune system. We are utilizing the tools of mode ...
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VP, Regulatory Affairs
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Director, Global Regulatory Affairs
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EMD Serono Billerica, United StatesWork Your Magic with us Start your next chapter and join EMD Serono. · Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solut ...
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Regulatory Affairs Specialist I
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Senior Regulatory Affairs Director
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AstraZeneca Waltham, MA, United StatesWould you like to apply your global Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?At AstraZeneca, we do this with the upmost integrity even in the most difficult situations be ...
Senior Manager/Associate Director, Regulatory Affairs - Waltham, United States - Meet
Description
185000 USD USD Waltham, United StatesPermanent
Meet is working with a dynamic and innovative biopharmaceutical company dedicated to advancing Neuroscience therapies through cutting-edge research and development. They have a focus on improving patient outcomes, and are at the forefront of clinical trials that push the boundaries of medical science.
They are actively hiring a Senior Manager/Associate Director, Regulatory Affairs to act as the regulatory lead on multidisciplinary projects and clinical study teams, to provide input on documentation and procedural requirements defined by regulatory authorities. This will include submission delivery strategy, reviewing documents, and the analysis of procedures that are used during development.
You will also be responsible for the following;
Creating, reviewing, and contributing, and editing submissions to support development including US Investigational New Drug (IND) submissions, Canadian and EU Clinical Trial Applications (CTAs).
Ensuring appropriate planning, tracking, and alignment of content and timelines for regulatory submissions across indications and compounds.
Travel occasionally for meetings and conferences.
Keep up to date with regulations and guidance, interpret and notify appropriate colleagues and stakeholders.
Qualifications:
10+ years of experience in Regulatory Affairs in a Pharmaceutical company, Biotech, Biopharma, or CRO.
PhD, Masters Degree or Bachelor's of Science
Demonstrated track record of successful clinical trial submissions in Canada, US, and Europe required.
Demonstrated, hands-on experience, managing and preparing regulatory submissions especially Clinical Trial Applications outside of North America with a primary focus on European applications through the Clinical Trials Information System (CTIS)
Extensive knowledge in Phase III ability to help manage all activities in Phase III