- Actalent (Greenfield, IN)
- Job Title: CMC Regulatory Affairs Scientist Job Description As a CMC Regulatory Affairs Scientist , you will play a crucial role in the design and ... evaluation of studies to meet regulatory requirements. You will define regulatory strategies for US submissions and prepare CMC submissions to ensure their… more
- Lilly (Indianapolis, IN)
- …offering the following positions:** + Global Regulatory Strategy + Global Regulatory Policy + Global Regulatory Affairs : Product Communications + ... to make life better for people around the world. The Visiting Scientist Fellowship is a one-year postgraduate program that introduces participants to various… more
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral ... strategies and submissions for Lilly's commercial solid oral products. The regulatory scientist will be encouraged to demonstrate innovative regulatory… more
- Lilly (Indianapolis, IN)
- …medicines to patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will ... regulatory strategies and submissions for Lilly's commercial products. The regulatory scientist will be expected to demonstrate innovative regulatory… more
- ManpowerGroup (Austin, IN)
- …Regulatory Labeling Scientist , you will be part of the Regulatory Affairs department, supporting cross-functional teams including Quality Assurance, Food ... Our client, a leading organization in the food manufacturing industry, is seeking a Regulatory Labeling Scientist to join their team. As a … 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 technical ... the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage innovative … more
- Roche (Indianapolis, IN)
- …Clinical Decision Support (CDS) solutions. **The Opportunity** As a Principal Quantitative Scientist , you will act as a scientific leader for Real-World Data (RWD), ... requiring deep expertise and the ability to influence critical business and regulatory decisions. Your work will involve leveraging diverse data types, including… more
- Lilly (Indianapolis, IN)
- …(PV) + Experience in defined functional business areas, for example, medical writing, regulatory affairs , or clinical trial management. + Knowledge of quality ... the development and maintenance of IT systems as the representative of MQO, Regulatory Quality. + Partner with IT and the business on system related… more
- Sumitomo Pharma (Indianapolis, IN)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work… more
- Grifols Shared Services North America, Inc (Indianapolis, IN)
- …and unmet needs within the therapeutic areas + Serves as an information scientist and colleague to top level academic physicians and researchers, select academic ... + Adheres to company policies and complies with applicable regulatory and legal requirements with highest ethical standards Skills/Qualifications/Education: (To… more