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A broad understanding of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation and drug product technologies, distribution in US/ex-US.
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Experience in Regulatory Reporting products like Axiom Controller View. Experience in regulatory reporting requirements for APAC/EMEA regulators will be a plus. 2 + Financial Services Industry experience, with background in Regulatory Reporting preferred.
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The objective of our consulting risk services is to provide clients with a candid and reliable overview of their risk landscape.
$102,900 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The Director of Student Affairs reports to the Associate Dean of Student Services and collaborates extensively with each of the programs and their different modalities as well as a multitude of university partners.
$141,900 a yearInternExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area.
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The Talent Acquisition Leader, Medical Affairs CPEAO is an experienced full cycle Talent Acquisition expert who will provide sourcing strategies and programs to identified critical business needs for functions across the Medical Affairs organization within Vertex.
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Drive awareness among Medical teams of the value created/ROI from oncology development-focused digital and AI technological innovation, and work with Oncology Scientific Affairs and Strategic Partnerships colleagues on external communications on these topics.
$269,400 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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The Associate Provost for Student Affairs and Dean of Students (AP/Dean) provides strategic leadership for the MGH Institute of Health Professions in the areas of student services, admissions and other enrollment services, and overall student success.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Responsible for maintenance of regulatory affairs product files to support compliance. Reviews, coordinates and approves CMC regulatory documentation for inclusion in INDs, NDAs, BLAs and worldwide submissions and compile all documentation and submit to FDA and foreign regulatory agencies.
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Understanding of banking regulatory hot topics, focus areas, and concepts, such as Fair Lending, Unfair or Deceptive Acts or Practices, Fraud Prevention, Capital and Liquidity Management, etc. As a Banking Compliance Risk Experienced Manager, you will get the opportunity to grow and contribute to our banking clients' business needs by providing in-depth technical knowledge on emerging regulations and help organizations leverage efficiencies within the Regulatory Compliance Practice – all with the resources, environment, and support to help you excel.
$207,400 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The position requires a bachelor’s degree, or foreign equivalent, in regulatory affairs, biotechnology, pharmaceutical science, or closely related field. We are seeking a Senior Associate, Regulatory Affairs Specialist to join the RA team at Relay TX. This is a professional-level position responsible for regulatory and compliance functions, and operational support at Relay TX. This position reports to the Senior Manager of Regulatory Affairs, and will collaborate with pharmaceutical and clinical development teams, as well as external publishing vendors.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The Associate Director, Regulatory Affairs CMC will lead CMC regulatory strategy to support global development and lifecycle. Agios Pharmaceuticals is searching for a dynamic Associate Director of Regulatory Affairs - CMC to join our Regulatory Affairs team.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Ph. D. with over 10 years of experience in pharmaceutical regulatory affairs, of relevant experience in biotech or pharmaceutical industries. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions.
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The Director of US Regulatory Operations (RegOps) is responsible for formulating and implementing operational management creating a best- in -class US regulatory operations team and technology leadership/ownership (Veeva PromoDocs) of Ipsen’s Advertising/Promotion and Labeling submissions along with associated tools.
$259,600 a yearFull-timeExpandApply NowActive JobUpdated 17 days ago - UpvoteDownvoteShare Job
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The Medical Affairs Operations and Medical Information Scientist will be accountable for Medical Information systems, processes, operations, and deliverables for Orchard's investigational and approved hematopoietic stem cell - gene therapy (HSC-GT) clinical programs.
Full-timeExpandApply NowActive JobUpdated 17 days ago
Title: regulatory affairs Company: Turnstone Biologics in Waltham, MA
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