- Lilly (Indianapolis, IN)
- …cross-functional partners for the following: + CMC development, manufacturing changes, CMC submissions and CMC regulatory requests, + Company ... + Product Team Leaders and Business Unit Leadership + Regulatory (including Device and CMC regulatory...Unit Leadership + Regulatory (including Device and CMC regulatory ) + Affiliate Medical Leadership/Clinical Research… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... of drug candidates to support clinical trials, product commercialization, and regulatory submissions. The position presents an opportunity to lead dynamic teams… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements. Ability to address key CMC regulatory questions that enable clinical studies and support marketing ... optimization of synthetic drug candidates to support clinical trials, regulatory submission, and product commercialization. The position presents an opportunity… more
- Cardinal Health (Indianapolis, IN)
- … submissions within the discipline of chemistry, manufacturing, and controls ( CMC ). The _Sr. Coordinator, Regulatory Submissions Operations_ will use ... **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Deloitte (Indianapolis, IN)
- …experience + 4+ years of experience in Life Sciences Pharmaceutical R&D regulatory domain. Experience to include: introducing new technologies like GenAI, AI/ML, and ... automation for pharmaceutical regulatory content or regulatory intelligence; Veeva RIM...generating submissions packages + Experience with submissions management, labeling, CMC change control and/or LCM processes + Understanding of… more
- Cytel (Indianapolis, IN)
- …Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls ( CMC ) data analysis. You are excited and enthusiastic, motivate your teams to ... **Position Overview:** We are seeking a highly motivated Biostatistician to support CMC projects across the drug development lifecycle. The ideal candidate will have… more
- Lilly (Lebanon, IN)
- …the site and for potential assignments across Product Research & Development ( CMC ) and manufacturing. + Works closely withleaders to determine potential new products ... direct responsibility. + Build strong technical and business relationships with CMC organizations, as well as partnering manufacturing organizations. + Working with… more
- Lilly (Indianapolis, IN)
- …lifecycle of an asset ranging from the discovery/development interface through regulatory submission and post-approval changes. We work to improve patient outcomes ... + Partner with cross-functional teams to ensure seamless integration of CMC development activities with other areas including discovery, toxicology, clinical… more
- Lilly (Lebanon, IN)
- …and biologic drug substance processes. This role will collaborate with the parent CMC development organizations to understand the needs of the portfolio and PAT to ... and manufacturing to deliver material and information for clinical trials and regulatory submissions. + Welcome varied perspectives to create new solutions. +… more