- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience orPhD. with 6-8 years pharmaceutical industry experience and… more
- Acadia Pharmaceuticals Inc. (Princeton, NJ)
- …to conduct global drug development and commercial activities. Primary Responsibilities Supports CMC regulatory affairs activities for marketed products and ... related field. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.… more
- Merck & Co. (Upper Gwynedd, PA)
- … issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company ... Development, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory CMC , Regulatory Strategy Development, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to ... collate the necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external… more
- Merck & Co. (Rahway, NJ)
- …teams, partner functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO ... tools and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops to ensure manufacturing readiness aligns… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations,… more
- The Fountain Group (Cambridge, MA)
- The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This ... total experience working in Pharma with at least 3 years of Regulatory CMC experience (manufacturing and testing). Experience delivering CMC content for… more
- Mirum Pharmaceuticals (San Mateo, CA)
- …it done, and have fun, seriously. POSITION SUMMARY The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory ... documents). In collaboration with Regulatory project managers, Regulatory Labelling and Regulatory CMC ,...industry with a minimum of 8 years in Global Regulatory Affairs , experience with major Health Authority… more
- Legend Biotech US (Somerset, NJ)
- …Serve as a liaison between internal departments (eg, research, toxicology, pharmacology, CMC , regulatory affairs ) and eternal partners (eg CROs) ... cross-functional team, ensuring adherence to IND submission timelines, budgets and regulatory requirements and acting as central point of communication between… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC , Marketing). Minimum of… more
- Vertex Pharmaceuticals (Boston, MA)
- …improvement. Interact with internal cross-functional teams, including Analytical Development, AS&T, CMC , Supply Management, Regulatory Affairs , Program ... with ICH/EMA/USP/Ph. Eur. Guidelines and internal procedures. Work with CMC technical SMEs and Regulatory to prepare and review QC related sections of IND,… more
- Glycomine (Boston, MA)
- …etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Translational Medicine and Program Leadership to ... and working closely with relevant team members involved in study set up ( CMC , Reg, etc). Ensure timeline collection of all start-up documents (example ethics… more
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC . **How you will contribute:** + Plan, execute and manage regulatory submissions for assigned compounds in various… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Information Management system. **Qualifications** + Bachelor's degree and 12+ years of experience in CMC Regulatory Affairs ( CMC RA) or other relevant ... guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs , and affiliates on internal meetings and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director, Regulatory Affairs - CMC (Manufacturing)** . This position will ... report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing facility located in… 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
- Lilly (Indianapolis, IN)
- …to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage ... 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… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA- CMC ) leads and manages the ... scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities… more
- Lilly (Indianapolis, IN)
- …need 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
- Gilead Sciences, Inc. (Foster City, CA)
- …scientific degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs , and CMC technical areas ... of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio...process in close partnership with other functions in PDM, Regulatory Affairs , and Clinical Development. + Exercises… more
