- Sumitomo Pharma (Indianapolis, IN)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Provide clinical and medical expertise across all stages of drug development, from preclinical transition to post-marketing. + Stay... Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions,… more
- Novo Nordisk (Bloomington, IN)
- …model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized ... Associate Engineers and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry organizations + Participate… more
- Highmark Health (Indianapolis, IN)
- …in a fast-paced and collaborative environment. **ESSENTIAL RESPONSIBILITIES** + Monitor FDA -approvals, drug manufacturer pipelines, assess drug utilization ... of high risk members. + Gateway - Assist in the development of Gateway's Drug Formularies by monitoring FDA -approvals and drug manufacturer pipelines,… more
- Lilly (Indianapolis, IN)
- …awareness within the organization. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping ... standards, practices, and equipment specific to parenteral products. + Familiarity with regulatory guidelines ( FDA , EMA, ICH) and experience with regulatory… more
- Novo Nordisk (Bloomington, IN)
- …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal ... model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized… more
- Novo Nordisk (Bloomington, IN)
- …model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized ... Associate Engineers and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry organizations + Lead… more
- Lilly (Indianapolis, IN)
- …of developing and ongoing initiatives (policies, practices, guidance, regulations, etc.) at the FDA , EMA, and other regulatory agencies as it relates to B-RA. ... in risk management programs and activities; 2 years of experience in supporting regulatory submissions to FDA /EMA with focus on analytic review and /or… more
- Lilly (Indianapolis, IN)
- …the pharmaceutical or life sciences industry. + Proven experience leading or supporting regulatory inspections (eg, FDA , EMA). + Strong knowledge of GxP ... will ensure that GISQ and Tech@Lilly are consistently prepared for regulatory inspections and that inspection-related knowledge is institutionalized and continuously… more
- Novo Nordisk (Bloomington, IN)
- …sterility assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal ... model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized… more
- Lilly (Indianapolis, IN)
- …Director will also interact with external consultants, opinion leaders, and worldwide regulatory agencies, and will provide oversight for responding to medical and ... regulatory questions and requests related to products. The Senior...with current local and international regulations, laws, guidance (eg FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company… more