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As part of the larger technology team working on new consumer technology, your work will have a large impact to hardware, internal software developers, ecosystem, and ultimately the lives of Amazon customers.
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Sr. Regulatory Project Manager (Biotech or Pharmaceutical exp.) PLEASE NOTE: Candidates need a minimum of 6 years’ experience in either the Biotech or Pharmaceutical industry along with experience developing and implementing best practices for preparing major global regulatory filings.
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In-depth knowledge of GxP guidelines (GMP, GLP, GCP, GDP, GVP) and regulatory requirements (21 CFR Part 11, EU Annex 11). Ensure that all GxP systems and processes comply with relevant regulatory standards, including FDA, EMA, and other global regulatory bodies.
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Knowledge: In-depth knowledge of GxP guidelines (GMP, GLP, GCP, GDP, GVP) and regulatory requirements (21 CFR Part 11, EU Annex 11). Regulatory Compliance: Ensure that all GxP systems and processes comply with relevant regulatory standards, including FDA, EMA, and other global regulatory bodies.
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Adaptability: Ability to adapt to changing regulatory environments and industry trends. Job Title- Senior Regulatory Compliance Lead. Certifications: Relevant certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar are a plus.
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The VP, Head of Medical Affairs, Oncology, will be a strategic partner for the assets under his/her responsibility, and will lead a dynamic US-based group overseeing the medical strategy and operational execution of all the multiple functions and therapeutic indications for all marketed products, products in development and provide expertise in business development, as required.
$270,000 - $396,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The MSL/Senior MSL will be a key member of the Field Medical Affairs team at Axsome. This position will be the primary communicator of Axsome science and will be responsible for executing the national medical affairs plan within a specified territory.
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This position will work closely with Clinical Operations, Clinical Supply Chain, Quality Assurance, Regulatory Affairs, and third-party CMOs. Strong cross-functional team leadership and project management skills are essential requirements of the role.
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Previous experience as a clinical research coordinator, regulatory associate, and/or start-up specialist is valuable. Expertise in sponsor-initiated clinical research, regulatory compliance, and Phase 2-4 clinical research with an understanding of the site Study Coordinator role.
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Working closely with Corporate Affairs as well as the US organization, this individual will be responsible for leading proactive external engagement with key patient advocacy groups (PAGs) and umbrella kidney and immune-mediated diseases (IMD) groups.
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Reporting to the Head of Global Regulatory Affairs (GRA), the Global Regulatory Strategy Leader (GRSL) CMC is responsible for developing and implementing global regulatory strategies to advance the development of the diverse candidates in the Gates MRI portfolio.
$230,000 - $270,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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As part of the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs – Pharmaceuticals. Leads the Early Development Pharmaceuticals GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology.
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Summary: Develop and manage the commercial distribution, commercial supply chain, and trade affairs for a new product launch at Apnimed. 10+ years relevant experience in pharmaceutical commercial distribution and trade affairs.
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Ideal applicants may possess a Bachelor’s degree in sport management, recreation, student affairs, or related field and/or experience working in campus recreation, collegiate athletics, or recreation/fitness.
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consumer affairs jobs Title: regulatory affairs in Cambridge, Anoka, Minnesota
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