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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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A scientific degree with directly relevant professional experience in global CMC regulatory affairs and CMC technical areas of at least 15 years with a BA/BS, MA/MS, PhD or PharmD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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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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Communications experience with Institutional Review Board (IRB) or other regulatory units preferred. The candidate will lead and manage FDA Center for Biologics Evaluation and Research (CBER) IND & IDE application preparation and submission; IND & IDE maintenance including reports and amendments using Florence Healthcare eBinders; preparation for internal and external compliance reviews of FDA related regulatory documents; and assisting IND/IDE Study UW clinical Principal Investigators with protocol development for compliance with the Code of Federal Regulations.
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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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Heb jij de drive en skills om als Regulatory Counsel het verschil te maken? Dit is jouw kans om het verschil te maken in de verdere groei van onze organisatie en jouw rol als Regulatory Counsel.
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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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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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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.
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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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Leads and collaborates in the development of post-approval global CMC regulatory strategies for an approved cell and gene therapy product. The Director, Regulatory CMC (Chemistry Manufacturing Controls) is responsible for the development and implementation of post-approval global regulatory CMC strategies for a marketed cell and gene therapy product.
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Experience with systems implementation and automation a plus, inclusive of Workday (and Prism), Alteryx, or other Regulatory Reporting tools such as Nasdaq (legacy AxiomSL ControllerView), Vermeg, Regnology, Wolters Kluwer, or Fed Reporter, Inc.
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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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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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regulatory job Title: regulatory affairs specialist Company: Pwc
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