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OBJECTIVES/PURPOSE OF JOB: The Senior Director of Global Regulatory Operations is responsible for directing and managing the Regulatory Operations function consisting of operational strategy; development; implementation and maintenance of operational processes; regulatory publishing, including submissions tracking and archival activities; management of GRA SOPs and departmental CAPAs.
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Authorities: Reach decisions within the specified area of responsibility as well as delegate tasks/decisions to qualified employees, while retaining responsibilityUnder leadership of EEO and in coordination with Industry and Government Affairs, manage the development of policy and regulatory positions for VWGoA for the US market and ensure alignment with Global Group policy positions and strategy.
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Associate Director of Regulatory Affairs, Combination Products, will be responsible for providing regulatory guidances to devices / combination product development and life cycle management, including generic products, 505B2 NDA products and biosimilars, preparing and reviewing submissions.
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You will:Foster professional growth and development for your direct reportsUse your extensive Regulatory and product development clinical and non-clinical strategy experience for all phases applications in the US and Canada.
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As a Regulatory Affairs professional within AstraZeneca, you will play a key role in channeling our scientific capabilities to make a positive impact on changing patients' lives. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs.
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Minimum of 5 years professional experience in a related area such as Research & Development, Technical Product Development, Quality, Regulatory Affairs, Clinical Research, or Medical Writing Knowledge of FDA regulations and standards for submissions of pharmaceutical products 1-4 years writing experience as a medical writers in the healthcare industry preferred.
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We are seeking a highly experienced and strategic CMC Regulatory Affairs professional to join our growing team. Provide mentorship and leadership to junior regulatory staff and contribute to the development of the regulatory affairs function within the company.
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A scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or10 years with an MA/MS, PhD, PharmD, or MD.
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Experienced in regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain.
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A scientific degree with directly relevant professional experience in small molecule product development, global CMC regulatory affairs, and CMC technical areas of at least 12 years with a BA/BS or 10 years with an MA/MS, PhD, PharmD, or MD.
$237,660 - $307,560 a yearFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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The Director, Global Regulatory Affairs, is a strategic role that will be responsible for developing, coordinating, and implementing regulatory strategies for early and/or late stage development programs for innovative biologic and small molecule products, as well as marketed products.
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Our client, a Reputable, Global Pharmaceutical Company, is seeking a Regulatory Affairs Strategy professional at the Director level. The company is growing exponentially with a focus in drug development within the oncology space; this hire is purely due to growth.
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Develop and implement Regulatory Affairs strategy for Oncology programs. The position will report directly into the VP of Regulatory Affairs. 8+ years of Regulatory Affairs Strategy experience.
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Are you a regulatory affairs and energy policy professional with experience in the RTOs (PJM), FERC and State Commissions? Track Federal Energy Regulatory Commission, PJM, State Public Utilities Commission (PUC), and other federal and state agency policies that impact Companys’ business and coordinate with appropriate functional groups within the Company (Development, Power Marketing, Finance, Asset Management) to ensure policy impacts to our business are understood.
$165,000 - $175,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Axsome Therapeutics is seeking an Associate Director/Director, Regulatory Affairs Advertising & Promotion to The Associate Director/Director, Regulatory Affairs Advertising & Promotion will help to establish and implement the promotional regulatory strategy for the company and will work with the Executive Director, Regulatory Affairs Advertising and Promotion to ensure professional and efficient interactions between the company and Office of Prescription Drug Promotion (OPDP.
$160,000 - $185,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
professional development jobs Title: director regulatory affairs in Aurora, Illinois
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