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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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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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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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A Juris Doctor (JD) or Master's degree in Regulatory Affairs is preferred. Job Description: We are seeking a highly organized and detail-oriented Regulatory Affairs Manager to join our team.
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Represents CMC regulatory affairs in major disease area/program/sub-function/regional area in senior internal management and governance bodies (Senior Leadership Teams, Committees, Review Boards, etc.
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Position SummaryThis position is a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients.
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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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The Senior Director, Regulatory Affairs will drive global Regulatory strategy for the Spur product development portfolio, advancing clinical stage programs in the gene therapy arena.
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Under the supervision of the Regulatory Program Manager of the Regulatory Review Unit, the Assistant Regulatory Affairs Coordinator (ARAC) supports the clinical research efforts of the 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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In this role, the Market and Regulatory Affairs Lead will participate as a stakeholder in RTO/ISO stakeholder processes, serve as the liaison for trade groups and collaborate with industry stakeholders to address issues that are relevant to LRE interests throughout the country.
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Pepsico.com. The Public Policy and Government Affairs (PPGA) team helps PepsiCo navigate the increasingly volatile and complex policy and regulatory landscape in which our company operates.
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The successful candidate will work collaboratively with the dynamic Federal Legislative Affairs team, as well as regulatory and business teams, to develop policy positions, formulate lobbying strategies, and coordinate Hill outreach to drive desired outcomes on critical issues.
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Acumen Pharmaceuticals is seeking a Director, CMC Regulatory, reporting to the Vice President, Regulatory Affairs, to lead the development, implementation, and execution of CMC regulatory strategy, including global submission strategy for investigational applications, clinical trial support, compliance, marketing application strategy, and CMC change management, ensuring compliance with global regulations (e.g., FDA, EMA, MHRA, HC, PMDA, CFDA, ANVISA.
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The Sr. Specialist, Regulatory Affairs will support the development of global Chemistry, Manufacturing and Controls (CMC) regulatory strategies and follow-through to implementation for assigned products/projects; this includes the authoring and/or review of Module 3 CTD and Module 2 sections.
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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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regulatory affairs jobs Title: sr affairs associate Company: Thermo Fisher Scientific
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