- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.Participate ... for bringing the issue and potential solutions to the Head of US Regulatory Affairs ... global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day… more
- Merck & Co. (North Wales, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... the entire life cycle of the drug.Provides leadership as head of the Global Regulatory ...release from our company to external agencies and investigators.Represents Global Regulatory Affairs (GR) within… more
- Genmab (Plainsboro, NJ)
- …seeking a Senior Director, USMA Solid Tumor Portfolio. This role will report to the VP/ Head of US Medical Affairs and will be responsible for building and ... and relevant studiesProvides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of the evolving scientific &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MDR and relevant vendors. Internal stakeholders: Global Safety, QPPV office, Global Development, Product Supply, Regulatory Affairs (NNI/NNCI) marketing, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...difference? The Position As North America responsible person, the head of Patient Safety will act as the safety… more
- Genmab (Plainsboro, NJ)
- …this role will include stakeholders in the business domains Field Operations, Medical & Regulatory Affairs and US and Japan Market and Commercial Teams (and ... Information Security will report directly to the VP and Global Head of Information Security and IT...and Genmab Security Operations TeamBusiness leaders (eg, VP Medical Affairs , VP Regulatory Affairs , GM… more
- Merck & Co. (North Wales, PA)
- …collaborations with stakeholders in Biostatistics, Clinical Research, Data Management, Regulatory Affairs , and IT.Primary Responsibilities : Determines the ... drugs and vaccines for the benefit of patients and global human health. Reporting to the head ...skills; experience collaborating with statisticians, clinicians, data managers, and regulatory and working in a global environment… more
- Morgan Stanley (New York, NY)
- …gaps/conflict and path to resolution -Provide overall support to Global Head of Regulatory Affairs -Manage/oversee contingent resources Skills required ... agencies that govern the firm's businesses. Background on the Team The Global Regulatory Affairs Program Office serves as a leader and executive sponsor… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …content. **Interface with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head , Global Regulatory Affairs Marketed Products and ... + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned… more
- Sumitomo Pharma (Columbus, OH)
- …. **Job Overview** The Vice President, Head of Medical and Scientific Affairs ... and medical information for key stakeholders. The Vice President will lead the global medical affairs functions for investigational and marketed products. **Job… more
- Sanofi Group (Cambridge, MA)
- …law. The Head of Rare Diagnostics is a key member of the Rare Global Medical Affairs leadership team in the Rare Disease franchise. The candidate will ... will work closely with the leadership of Rare Disease Global Medical Affairs and Global ...statement of work, joint steering meetings, design control oversight, regulatory assessment and launch readiness. + Serve as the… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Manager Date: Nov 25, 2024 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance ... & Regulatory Affairs Contract Type: Permanent Location: Cary,...**Purpose** The Global RA Manager supports the Global Regulatory Teams in the translation of… more
- Takeda Pharmaceuticals (Columbus, OH)
- …activities pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and ... to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for...Development and leadership of the following activities at a global level in collaboration with Head of… more
- ServiceNow, Inc. (District Of Columbia, DC)
- …Global Government Affairs and Public Policy. Reporting to the Vice President, Head of Global Government Affairs and Public Policy, this individual ... better for everyone. ServiceNow is looking for a government affairs professional to join a global team...and inform ServiceNow's leadership on all key policy, legislative, regulatory , and global issues that might impact… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to ... Responsibilities:** + Be a strategic thought partner to the Head of Regulatory about complex problems, current... sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team,… more
- AbbVie (North Chicago, IL)
- …you will be added to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles (US and Canada) are: 1. ... a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head ...cross-functional team who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution. + ... for bringing the issue and potential solutions to the Head of US Regulatory Affairs ...Participate in global product team meetings to provide US … more
- Merck (Philadelphia, PA)
- …accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. ... life cycle of the drug. + Provides leadership as head of the Global Regulatory ...our company to external agencies and investigators. + Represents Global Regulatory Affairs (GR) within… more
- Englewood Lab, Inc (Totowa, NJ)
- Title: Regulatory Affairs Associate Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: + Assist the Manager ... of Regulatory Affairs to create and collate product master files (dossiers),...elements of ISO 13485:2003. + Maintain familiarity with changing global regulatory requirements. + Responsible for any… more
- Amazon (Arlington, VA)
- …remove blockers, and will deliver results across the world. You will report to the Head , Licensing & International Regulatory Affairs for Project Kuiper and ... unique opportunity to work in the development of a global broadband satellite communication system and make a difference...bridging the digital divide. The Senior lead, Licensing and Regulatory Affairs works to align the licensing… more
- Olympus Corporation of the Americas (Westborough, MA)
- …HCP (peer-to-peer) as well as societal engagement. + Clinical Research: To support the Global Head of Clinical Affairs in the conception, development, and ... entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Respiratory (GLMAR) is a board-certified,… more
