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Marilyn Kiral PharmD, PhD Regulatory Affairs Director-Oncology, Global Regulatory Affairs at AstraZeneca Frederick, Maryland 500+ connections

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Amgen Jobs - Regulatory Affairs Jobs

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Accelerated Approval in Oncology: FDA Touts Successes

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Options in Regulatory Affairs- Specialties and Skill Sets; Nancy Pire-Smerkanich and David Locke (March 2015) Escalation of Oncologic Services at the End of Life Among Patients with Gynecologic Cancer at an Urban Public Hospital ; Terry Church, et al (February 2015).

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About the Regulatory Profession. The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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Oncology Regulatory Affairs | FDA

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Rachel van Altenburg - Regulatory Affairs Associate

Two critical challenges were identified while developing the system framework: 1) Creation of a knowledge base for the pharmaceutical regulatory affairs domain to conceptualize and formalize FDA’s drug approval process 2) Enabling semantic understanding of user queries to capture and support the information need in a way intuitive to the user.

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Regulatory Affairs Manager – EU Oncology. Amgen Oncology. Amgen is a full-scale biotechnology company that integrates the nimble and innovative culture of a small biotech with the stability, heritage and experience of a large pharmaceutical company.

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A career in Oncology | GSK

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Roman Levytskyy, PhD, MBA - Staff Scientist, Regulatory

About the Regulatory Profession. The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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A First for FDA: Cancer Treatment Approved for Any Solid

GSK Oncology has a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer, specifically in four areas of cancer research: Cancer Epigenetics, Immuno-Oncology, Oncology Cell & Gene Therapy and Synthetic Lethality.

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Vice President, Head Oncology Regulatory Affairs at Sanofi Jeremy G Chadwick, PhD SVP and Head Global Regulatory Affairs and Head Global Development Office at Takeda Pharmaceuticals

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Jeannie Tay, BCNSP - Regulatory Affairs Executive

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Regulatory Affairs Manager - EU Oncology | Amgen

Learn how the clinical regulatory affairs and medical writing services Medpace provides can help guide your program forward throughout it's lifecycle. Learn how the clinical regulatory affairs and medical writing services Medpace provides can help guide your program forward throughout it's lifecycle. Regulatory strategy and agency

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Jinrong Liu - Senior Manager, US/Canada Regulatory

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The Seattle Genetics Regulatory Affairs Fellowship is a one-year, experiential program at Seattle Genetics based in Bothell, WA. The purpose of this program is to prepare PharmD fellows for career opportunities in pharmaceutical Regulatory Affairs – Advertising and Promotion by providing in-depth biopharmaceutical industry experiences and enhancing clinical knowledge.

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A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker Posted 23 May 2017 | By Zachary Brennan The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a …

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How Should We Staff Regulatory Operations Teams? A

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FDA Drafts Guidance on Oncology Companion Diagnostics | RAPS

A majority of oncology treatments granted accelerated approval over the last 25 years have gone on to demonstrate a clinical benefit, US Food and Drug Administration (FDA) officials write in a review published in JAMA Oncology last week.. But the review notes that 5% of those drugs were eventually withdrawn from the market and that drugmakers have not yet completed postmarketing requirements

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Regulatory Affairs Professionals Society | RAPS

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She has held positions in Regulatory Affairs, Quality & Compliance, Clinical Affairs & Operations, Data Management, Statistics and Medical Writing. She currently works for Medtronic as a Principal Clinical Quality Specialist overseeing the quality and compliance of the diabetes clinical program.

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James Burrus - Director, Regulatory Affairs (Advertising

View Jeannie Tay, BCNSP’S profile on LinkedIn, the world's largest professional community. Dissertation titled “Oncology database on interactions between anticancer drugs and psychotropics”. Published in European Journal of Cancer Care, December 2009. Jeannie Tay, BCNSP. Regulatory Affairs Specialist .

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2018 Cohort | USC Department of Regulatory & Quality

Neal has also received Regulatory Affairs Certification from RAPS. Simone E. Turnbull, DRSc, MS is currently a Senior Manager of Regulatory Affairs at Chattem, Inc., the U.S. consumer healthcare division of Sanofi. Chattem manages the Allegra® and Nasacort® brands, and is the platform for Sanofi Rx to OTC switches in the United States.

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2010 Cohort | USC Department of Regulatory & Quality

A member of the EMEA Haematology/Oncology Regulatory Affairs team. I specifically worked on a multiple myeloma product and was involved with supporting the regulatory manager and regulatory liaison with EU-centralised submissions in the EMEA region. This involved supporting with lifecycle submissions in the EU, and providing support to ex-EU

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Peggy Carter - VP, Head Regulatory Affairs, Medical

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PharmD Fellow—Oncology Regulatory Affairs – Advertising

Nov 22, 2016 · In this installment of “Novartis Presents: Women in Science,” we hear from Hannah Mosca, who serves as Director of Operations, Oncology Regulatory Affairs, Oncology Global Development (OGD) and Global Medical Affairs (GMA) at Novartis.