- Parexel (Indianapolis, IN)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… more
- Parexel (Indianapolis, IN)
- …development and approved programs, helping to shape the future of life-saving therapies. As a ** CMC Regulatory Affairs Senior Associate** , you will play ... scientific discipline (advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. +… 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 ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… 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 ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
- Bausch + Lomb (Indianapolis, IN)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... Bachelor degree or equivalent, Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment + Ability to… more
- Parexel (Indianapolis, IN)
- **Join Parexel as a Regulatory Affairs Strategy Lead** Are you a strategic thinker with a passion for navigating the complex world of global regulatory ... plans? If so, we'd love to connect. We're seeking Regulatory Affairs Strategy Leads who will be...programs from early development through approval * Coordinate cross-functional regulatory activities ( CMC , nonclinical, clinical) to meet… more
- Bausch + Lomb (Indianapolis, IN)
- …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... or equivalent; Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, Nutritional,… more
- Sumitomo Pharma (Indianapolis, IN)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
- Sumitomo Pharma (Indianapolis, IN)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… 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) ... regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in...for 10 years + Direct experience in clinical and CMC regulatory sciences + Experience in applicable… 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) ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more