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BryceTech is looking for an experienced Regulatory Affairs Analyst to support the DHS FEMA, Office of Response and Recovery, CBRN program, supporting the Office of Emerging Threats Professional and Technical Services Contract.
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What we look for: A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 20 years with a BA/BS, MA/MS, PhD or PharmD.Demonstrated organizational leadership skills at both functional and enterprise levels.
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Johnson & Johnson is recruiting for a Senior Director, CMC Regulatory Affairs Biologics – New Modalities, located in either Horsham, PA; Titusville, NJ; Raritan, NJ; or Beerse, Belgium. Reporting to the VP CMC Regulatory Affairs (RA) Biologics, the Senior Director, CMC RA Biologics.
$187,000 - $322,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new/modified product, regulatory operation and processes, post-market surveillance.
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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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Balance reporting requirements to multiple constituencies including; Centene Corporation regional vice president, state health plan president, chief operating officers and Corporate regulatory and government affairs staff.
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Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions Regularly informs regulatory leadership of important timely issuesStays abreast of regulatory procedures and changes in regulatory climate.
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Reporting into the Senior Manager for Origination, the Senior Regulatory Affairs Specialist’s primary responsibilities are to support Repsol’s natural gas trading/origination teams through communication of regulatory changes affecting natural gas and electricity markets and the external advocacy for the protection and betterment of Repsol’s commercial interests.
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Job DescriptionJob DescriptionReports to: Manager, Environmental, Health, Safety & Security (EHSS)MAIN PURPOSE (Briefly state the job's overall objective)Provides product stewardship, regulatory, and sustainability support and expertise to business units for complying with EHSS global regulatory requirements.
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The analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and external IRBs.
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Reporting to Vice President, Government and Regulatory Affairs - North America, this position is responsible for managing highly skilled regulatory affairs teams focused on internal compliance while supporting regulatory strategy and risk mitigation for Livingston and our clients.
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Hexcel is currently seeking a Product Safety/Regulatory Affairs Specialist for our Salt Lake City, UT, USA location. Qualifications:A relevant degree (Chemistry, Environmental Science, Health and Safety or equivalent), with 3+ years of work experience in a product regulatory affairs/stewardship.
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The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RCMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cycle management of unique and technologically complex products.
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Communicate regularly and effectively in a cross-functional matrix with development, origination, fundamentals, finance, and political & regulatory affairs staff to translate regulatory and market issues into business impacts and opportunities to benefit the position of Pattern's new and core business interests in MISO and other priority markets.
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Under the supervision of the Regulatory Program Manager (RPM) of the Regulatory Affairs Unit, the Regulatory Affairs Coordinator (RAC) supports the clinical research efforts of the Chao Family Comprehensive Cancer Center by providing comprehensive, regulatory management of cancer-related protocols in accordance with human subject federal regulations, internal standard operating procedures (SOPs), and University policies and procedures.
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regulatory affairs jobs Company: Novocure Inc in Lahaina, Hawaii
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