- Abbott (St. Paul, MN)
- …vessel closure devices, peripheral stents, and atherectomy devices. **The Opportunity** This ** Associate Director Regulatory Affairs** will work on-site at our ... Vascular Division. As a manager, the function of an Associate Director Regulatory Affairs is to combine...regulatory requirements. + Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Lilly (Indianapolis, IN)
- …that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of the Associate Vice President - Global ... which will center around topics that encourage innovation in drug development and regulatory review of genetic and neuroscience medicines + Critically review… more
- Gilead Sciences, Inc. (Foster City, CA)
- …& Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for ... create possible, together. **Job Description** You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** We are seeking an Associate Director, Regulatory Affairs CMC candidate to sit at our Foster ... City, CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is...of developing global CMC strategies in all phases of drug development including life cycle management + Collaborative, proactive,… more
- J&J Family of Companies (Spring House, PA)
- …at https://www.jnj.com/innovative-medicine **We are searching for the best talent for an Associate Director, North America Regulatory Leader to be located in ... House, PA; Raritan, NJ; or Titusville, NJ.** **Purpose:** The Associate Director, Regulatory Lead in Global ...industry experience is required. + An understanding of the drug product lifecycle from discovery to clinical trials to… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …state/province requirements and ROW licensing activities as applicable. The Plasma Regulatory Affairs Associate will monitor and perform administrative ... and services in more than 110 countries and regions. **Summary:** Plasma Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- Lilly (Philadelphia, PA)
- …are determined to make life better for people around the world. Responsibilities: The Associate / Manager, CMC Regulatory and IMP Manufacturing Operations is a ... hybrid role within CMC Development supporting the two functional areas. The Associate / Manager is responsible for CMC regulatory operations, CMC change… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on...project management skills as evidenced by past performance on drug development project teams + Ability to thrive in… more