- Sun Pharmaceutical Industries, Inc. (Whittingham, NJ)
- …archival of assigned global eCTDs and paper submissions using Regulatory Affairs systems/tool. Publishing includes; eSub Prep (Bookmarking; hyperlinking; ... us. DOWNLOAD OUR CODE OF CONDUCT The Senior Manager, Regulatory Affairs will handle publishing and coordinating...is responsible. Must understand and be updated with current Global Regulatory filing requirements and eCTD structure.… 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
- 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
- CSL Behring (King Of Prussia, PA)
- …stakeholders. Serves as a collaborator and key stakeholder to the Heads of Medical Affairs in the US and International, Global Commercial Development, Global ... The Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across... Global Clinical R&D, Global , Global Pharmacovigilance and Promotion Review Committee (PRC) on medical… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Manager Date: Sep 14, 2024 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, Pharmacovigilance ... & Regulatory Affairs Contract Type: Permanent Location: Cary,...to company success with collaboration from Therapeutic Area (TA) head 2) Accountable for global /regional regulatory… 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 (South San Francisco, CA)
- …you will be added to our talent pipeline and considered for future opportunities. Global Regulatory Affairs Strategy roles (US and Canada) can be ... 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
- 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
- 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 ... entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Global Lead Medical Affairs - Respiratory (GLMAR) is a board-certified,… 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
- Actalent (Jacksonville, FL)
- … Regulatory Affairs Specialist Job Description We are seeking an experienced Regulatory Affairs Specialist to head their own projects and submit ... environment and maintain positive communications and collaborations. Hard Skills + Medical Device Regulatory Affairs + Quality Assurance + GMP Medical Device +… 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
- Bausch Health (San Francisco, CA)
- …and effective aesthetic care options to consumers and physicians alike. The Manager, Regulatory Affairs provides direct support to Solta operations for their ... site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to ensure the effective...Should have over 7 years of experience as Sr. Regulatory Affairs Specialist. + Should have experience… 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
- Olympus Corporation of the Americas (Center Valley, PA)
- …as a principal assistant to the Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs . Responsible for management of the delivery of ... Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs , including... Global Head of Legal - Regulatory , Quality, Medical & Scientific Affairs . **Job… more
- Sanofi Group (Bridgewater, NJ)
- …progress to make a real impact on millions of patients around the world. The Global Medical Head of Rhinology and Gastroenterology (R&G) will report to the ... Global Medical Head of Immunology Alliance assets....development and commercial activities + Represent the SAGZ respiratory global medical affairs at medical meetings, advisory… more
