- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. **Job Summary** The Director / Senior Director , CMC , Drug Product Development will lead ... capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development and… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) ... experience for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable therapeutic area neuroscience and/or immunology… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Lilly (Indianapolis, IN)
- …and diverse portfolio of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the ... + Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus. + Strong leadership skills with a… more
- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism **Position Summary:** The Senior Director of TSMS - Tech Transfer is a strategic ... technical excellence, and fosters collaboration across development, manufacturing, and regulatory functions. **Key Responsibilities:** **Tech Transfer Leadership** + Lead… more
- Sumitomo Pharma (Indianapolis, IN)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director is… more
- Lilly (Indianapolis, IN)
- …+ Ensure process definition of critical parameters are in alignment with regulatory submission. + Ensure that each of the department and external partner ... operate in compliance with cGMPs, regulatory commitments and Lilly Functional Standards though appropriate oversight....plan (BP), cGMPs and internal standards. + Escalate to Sr . Management in a timely fashion risks to supply,… more