- Catalent (Manassas, VA)
- Associate Director , Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry ... patient, consumer and Catalent employee. The primary duty of the Associate Director , Regulatory Affairs is to support regulatory strategy for product… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned ... selected individual will function with a high degree of independence and provide regulatory oversight for assigned products, in order to optimize label and obtain… more
- George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Director , Regulatory Oversight position reports to the Associate Provost Research Integrity and Compliance (AP-RIC) ... oversight of the research radiation and laser safety programs. The Director , Regulatory Oversight works closely with Office of Research Integrity and Compliance… more
- Fidelity TalentSource LLC (Boston, MA)
- …the vibrant Fidelity Capital Markets trading floor? \u00A0We are looking for a Director of Regulatory Reporting, a leadership position within the team that ... Services, as well as for correspondent client broker-dealer firms. \u00A0\u00A0The Director is responsible for understanding the core businesses of the trading… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic ... oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.ResponsibilitiesCDx development: Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to ... DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in...indirect accountability for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's ... regulatory group in internal and external development project meetings....guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input with feedback… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You ... will lead a global regulatory team to develop and execute regulatory strategies for high impact projects while working with decision-makers across multiple… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The RoleThe Director of Product Disclosure Policy and Regulatory Strategy is responsible for establishing and administering guidelines for the ... Operations (FFIO) regulatory readiness focused on emerging regulatory matters impacting our business. The Director ...emerging regulatory matters impacting our business. The Director will:Be the primary day to day contact for… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The TeamAs a Compliance Director in Regulatory Management, we will expect you to have direct contact with the SEC, FINRA and other regulators on ... our Capital Markets division. You will be responsible for responding to regulatory inquiries and handling examinations related to Clearing and Custody and Capital… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is ... The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA,… more
- The University of Vermont Health Network (Burlington, VT)
- …mandated regulatory agency guidelines as appropriate. With the support of the Director , the Regulatory Coordinator is responsible for implementation of key ... JOB DESCRIPTION:Under the leadership of the AVP, Chief Regulatory Officer, the UVMHN Coordinator, Accreditation and Regulatory Affairs assists with the… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …operating and capital budgets for system-wide facilities maintenance expenses. The director oversees a comprehensive regulatory program designed to achieve ... health of our communities. About the Role:Job SummaryThe system director for Facilities Maintenance is accountable for the financial,...DNV accreditation, and compliance with many other regulatory agencies to include GAEPD, DCH, CMS, DOT and… more
- Insmed Incorporated (Bridgewater, NJ)
- …discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Beacon Hill Staffing Group, LLC (Raleigh, NC)
- …to apply to most work situations. Work is performed under the supervision of the Director and Assistant Director of Regulatory Affairs as well as the ... of administrative support and public contact duties in support of the Regulatory Division's functions. Distinguishing Features of the Class An employee in this… more
- Lennar Homes (Raleigh, NC)
- …wetlands, modules. Regularly interact with the Regional Environmental Manager (REM), Director of Construction, regulatory agencies, and division associates. ... Water Pollution Prevention Plans and Best Management Practices. Interact with the Director of Construction, Director of Land Development and Regional… more
- OU Health (Oklahoma City, OK)
- …and supports the Quality and Safety Manager, Medical Directors, and Administrative Director in meeting regulatory and accreditation standards. Participates in ... of equipment is performed and documented.Reports to the Lab Administrative Director and performs delegated tasks.Provides leadership and mentoring to department… more
