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Title: Senior Regulatory Affairs Specialist. Title: Senior Regulatory Affairs Specialist. Previous experience with 510k submissions, Health Canada, International Device Submissions Licensing and Registration experience.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Develop and write high-quality, scientifically accurate documents for regulatory filings, including preclinical and clinical study reports, protocols, investigator brochures, and regulatory submission documents.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Audit Manager - Regulatory Reporting. Leads/executes multiple regulatory reporting audits, and ensures that audit reports address key risks, are impactful, insightful, timely, error free, and concise.
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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). Adaptability: Ability to adapt to changing regulatory environments and industry trends.
ExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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Experience with Joint Commission accreditation processes and standards, or regulatory compliance experience. Minimum of 3-5 years of experience in regulatory affairs, compliance, or a related field within a healthcare setting.
ExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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BS or equivalent with 15+ years of related experience with demonstrated knowledge of drug development process is essential, as well as knowledge of laws and regulations affecting the pharmaceutical industry and regulatory experience.
$310,000 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. The Vice President, Regulatory Affairs & Quality is in charge of providing subject matter expertise on all matters related to FDA and global regulatory requirements, as well as leading the growth and responsibilities of the regulatory and quality department.
Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Deloitte Risk and Financial Advisory's Financial Services Industry (FSI) Risk, Data and Regulatory professionals help organizations identify the regulatory changes impacting their business and implement effective and efficient processes to manage regulatory, capital, liquidity and interest rate risks, respond to evolving regulatory environments and implement programs, measures, and tools to help clients with a specific focus on risk, data, and regulatory processes.
$207,763 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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A career in Treasury Advisory, within Risk & Regulatory Advisory, will allow you to advise financial institutions on developing strategies to optimize financial performance and risk management across financial risks, including liquidity risk, market risk, counterparty credit risk and interest rate risk.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.
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Minimum B.S. in biochemistry, chemistry, biology, or biochemical engineering, or related life science field, with a minimum of 8 years of relevant biopharmaceutical industry experience, ideally with biologics experience in Regulatory Affairs.
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The Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs. Minimum of 8-10 years of experience in regulatory strategy in a clinical-stage biotechnology company.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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The Chemistry Manufacturing Controls Manager will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another related life-science field.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development.
$266,200 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago
Title: regulatory Company: Flybreeze in Woburn, MA
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