- Regeneron Pharmaceuticals (Troy, NY)
- …are seeking a highly motivated and experienced regulatory professional responsible for overseeing CMC aspects of global submissions . This position would ... Regeneron is currently looking for a Staff CMC Regulatory Sciences Specialist for...+ Experience in managing non-US/EU markets global submissions + Strong knowledge of CMC regulatory… more
- Lilly (Indianapolis, IN)
- …Applications, Market Registrations And Post-Approval Submissions . The Research Scientist in Global Regulatory Affairs - CMC will leverage CMC technical ... technical expertise, to strengthen submission or minimize risk. * Reviews and approves CMC documents for global regulatory submissions , including … more
- Takeda Pharmaceuticals (Boston, MA)
- …having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred. ... and staff . Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and… more
- Eurofins (Indianapolis, IN)
- …are not limited to: + Leads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions + Takes a proactive ... strategies and submission content. + Makes technical decisions on CMC regulatory issues impacting product submissions across...but Optional: + Three or more years of direct global regulatory CMC experience, or equivalent experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …GRA - CMC Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC ... GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Responsible for preparing and/or overseeing the preparation of complex regulatory CMC submissions for investigational and commercial products in line with ... development matrix teams + Coach and mentor junior regulatory CMC staff **Minimum Qualifications:** + Have 8+...with strategic planning, problem solving, and working within a global matrix team environment, successfully managing CMC … more
- Bristol Myers Squibb (Seattle, WA)
- …analytical, process, manufacturing, quality, regulatory, etc., and key matrix leaders from CMC and Global Operation teams. Additionally, they will review and ... analysis, and summarizing strategies in technical reports, and communication with global health authorities with submissions . **Key Responsibilities:** + Drive… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to the analytical control strategy and data collection for regulatory submissions to support small molecule candidate progression from discovery to marketing ... focuses on staying ahead of technical changes and expectations in small molecule CMC development. This candidate is adept at identifying strategies and tactics for… more
- Lilly (Indianapolis, IN)
- …and regulatory submissions . + Possess deep understanding of the external global regulatory climate and emerging requirements; ability to address key CMC ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …The role will also be responsible for review and authoring of key CMC submissions , along with setting relevant standards and creating /maintaining associated ... until the completion of process performance qualification and subsequent CMC filing activities. + Development, characterization, optimization and troubleshooting… more