- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Global Regulatory Lead (GRL), reporting to the Executive Director , Senior Director ... or the EU-procedure regulatory expert on those projects. + Lead the Global Regulatory Teams, which coordinates cross-functional regulatory support for… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... global development, regulatory , and registration strategies. + The Director , Global Regulatory Lead supporting programs within BeOne's Hematology… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global ... Regulatory Lead (GRL) role is to develop and implement innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages ... regulatory strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous improvement in … more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will ... + Development of regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC development… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role responsible for overseeing and driving ... and Communication, Risk Management and Problem-Solving._** + Plan, execute, and oversee global regulatory projects, including preparation and submission of INDs,… more
- Lilly (Indianapolis, IN)
- …over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC ... + Development of regulatory strategy and update strategy based upon global regulatory changes. + Provide regulatory guidance to allow CMC teams to… more
- Lilly (Indianapolis, IN)
- …partner and support the needs of the US Business Unit, the Sr . Director will lead a team of regulatory personnel, providing administrative oversight and ... partners in support of marketed product activities. Additionally, the Sr . Director leads regulatory personnel...and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Provide… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience...technical success for the mitigation strategies proposed. + The Sr Director / Director will be accountable… more
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