- 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
- 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
- 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