- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary With the Head of Government Affairs & Public Policy, this position will help ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...medicines to the patients who need them.Responsibilities- With the Head of Government Affairs and Public Policy,… more
- Merck & Co. (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Takeda Pharmaceuticals (Boston, MA)
- …for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the ... regulatory data and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic,… more
- ADM (Quincy, IL)
- …Harvard, IL; Fort Collins, CO; St. Louis, MO** **Your Responsibilities** Reporting to the Global Head Regulatory Affairs this position will collaborate ... in NAM (eg AFIA, NASC) and at global level jointly with other regulatory colleagues and government affairs + Interact and guide specialists across the… more
- Sanofi Group (Bridgewater, NJ)
- …(TA) Head , Global Business Unit (GBU) Head and up to the Global Regulatory Affairs (GRA) Leadership Team (LT) as needed. The GRL is the primary ... internally and externally as "one GRA voice" with TA Head , GBU Head and up to the...pharmaceutical/biotechnology experience, including at least 10 years of relevant Regulatory Affairs experience (regionally and global… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Leads and expands Neuroscience Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications ... franchise structure.** **Strategic and thought leadership experience in medical affairs and Neuroscience.** **Experience successfully leading global … more
- Gilead Sciences, Inc. (Foster City, CA)
- …include but are not limited to: + Partner with stakeholders (eg, Medical Affairs , Business Conduct, Development, Regulatory Affairs , Legal and Commercial) ... a patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs , Insights, Digital and Analytics this individual will… more
- Ascendis Pharma (Princeton, NJ)
- …and services are fully compliant with Ascendis SOPs and US as well as global regulatory and compliance rules/law. Requirements . MD or MD/PhD or equivalent ... Head of US Medical - Endocrine Medical Affairs will report to the US General Manager with...Ascendis Pharma. . Works closely with Compliance, Legal and Regulatory to ensure that all US Medical Affairs… 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …a specific product in Gilead's global portfolio of biological products in CMC Regulatory Affairs . This position will provide leadership at a product level as ... (PDM) Project teams. The role will report directly to Head of CMC Regulatory Affairs ...degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and… more
- Ascendis Pharma (Palo Alto, CA)
- … Affairs will be responsible for supporting and developing global regulatory strategies for the oncology pipeline products encompassing clinical, ... in Palo Alto, CA and reports directly to the Head of Regulatory Affairs . Key...understand current global and regional trends in regulatory affairs and ability to assess the… more
- Englewood Lab, Inc (Totowa, NJ)
- …+ Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. + With the assistance of Head of R&D (or designee), create ... of Quality/ Regulatory . + Assist the Manager of Regulatory Affairs during periodic quality reviews, ...elements of ISO 13485:2003. + Maintain familiarity with changing global regulatory requirements. + Ability to work… more
- Philips (Chicago, IL)
- …manufacturing procedures to maintain quality and regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate with ... The Senior Regulatory Affairs Program Manager will play...& Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and… 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 ... other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Gastroenterology (GLMAG) is a board-certified,… more
- New York State Energy Research and Development Aut (New York, NY)
- … Affairs will report directly to the NY Green Bank's Managing Director, Head of Legal and Regulatory Affairs and be charged with anticipating ... other capital providers. New York is leading the nation in the fight on global climate change and the transition to a clean energy-powered economy. The Climate… more
- Pfizer (New York, NY)
- …with commercial priorities andregulatory requirements. The incumbent will: + Represent Global Regulatory Sciences (GRS) International Regulatory Sciences ... all projects and products are reflected in the relevant global regulatory strategy. This is accomplished through...Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs… more
- AbbVie (South San Francisco, CA)
- …+ Responsible for products within a Therapeutic Area & support the Global Regulatory Lead (GRL) & Therapeutic Area Head with the development & execution of ... YouTube and LinkedIn. Job Description Key Responsibilities + Responsible for providing regulatory strategy & support for global development. + Responsible for… more
- Englewood Lab, Inc (Totowa, NJ)
- …(QMS) in compliance with US 21CFR 210, 211. + Maintain familiarity with changing global regulatory requirements. + Assist with CARES Act drug reporting, Product ... document submissions to regulatory agencies under the direct supervision of the Head of Quality. + Assist the Manager during periodic regulatory reviews, … more
