- 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
- 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)
- …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
- 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
- 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...success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards ... and influencing the field as applicable. + Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… 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)
- …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)
- …patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Operations, Compliance & Process Excellence is ... accountable for overseeing Global Regulatory Affairs Operations across the entire...and succeed. + Able to influence without authority at senior (TET/TET-1) level. + Demonstrates agile leadership by seeking… more