- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... molecules and/or synthetic peptides, proteins or oligonucleotide. + Knowledge of global CMC regulatory requirements and guidelines for reporting post… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... products CMC science and manufacturing processes. + Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... synthetic molecule CMC drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… more
- Lilly (Indianapolis, IN)
- …+ Deep technical knowledge of CMC drug development science(s) + Knowledge of CMC global regulatory requirements and guidelines related to parenteral drug ... knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for... global regulatory expectations + Provide regulatory guidance to allow CMC development teams… more
- Bristol Myers Squibb (Indianapolis, IN)
- …Marketing Authorization Application (MAA) submissions + Lead the development and execution of global CMC regulatory strategies for activities conducted at ... We are seeking an experienced and motivated **Senior Director, Regulatory Affairs - CMC (Manufacturing)**...global change management + Provide additional ad hoc Regulatory - CMC support to RayzeBio manufacturing team +… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC...and regulatory excellence attributes as described in Global Regulatory Affairs white papers.… more
- Cardinal Health (Indianapolis, IN)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... approvals. More specifically, this role serves the function to support global , post-approval lifecycle regulatory requirements for Biologics and small-chemical… more
- Cytel (Indianapolis, IN)
- …with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs , to develop and implement appropriate statistical ... Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls ( CMC ) data analysis. You are excited and enthusiastic, motivate your teams to… more