- 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
- Merck & Co. (Rahway, NJ)
- …teams, partner functions including Global Science Engineering and Commercialization (GSEC), Quality, and CMC Regulatory Affairs , as well as, the GBO ... supplying more products than ever before.Reporting directly to the Senior Vice President (SVP) of Global Biologics Operations, the...and training programs for site and functional teamsPartner with regulatory affairs , quality and site tech ops… more
- Glycomine (Boston, MA)
- …etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Translational Medicine and Program Leadership to ... of life for patients, caregivers, and families. Job Description The Senior Clinical Project Manager/Clinical Project Manager is a team-player role responsible… 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
- J&J Family of Companies (Spring House, PA)
- …at https://www.jnj.com/innovative-medicine We are currently seeking a motivated Senior Scientist in CMC Regulatory Affairs to join our dynamic team. This ... communications in line with global product strategy. + Alert CMC Regulatory Affairs Management to...necessary CMC RA systems. **Leadership Competencies:** The Senior Scientist in Regulatory Affairs … more
- Bristol Myers Squibb (Indianapolis, 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)
- …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
- BeOne Medicines (Emeryville, CA)
- …seeking an experienced and instrumental regulatory professional to lead US biologics regulatory CMC team. This individual leads biologics regulatory ... based in China and cross-functional stakeholders in developing and executing biologics regulatory CMC strategies, oversees CMC -related regulatory … 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
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... guide the team to define and drive strategy for CMC regulatory dossier content and reviews this...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… more
- Boehringer Ingelheim (Ridgefield, CT)
- … complexity and/or business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and ... strength and competitive advantage lie with our people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory ... Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member… 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
- 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
- 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 ... guidances, and communicates changes in regulatory CMC information to project teams and senior ... guidance. + Collaborates with colleagues across the global CMC RA organization, Gilead Regulatory Affairs… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Ascendis Pharma (Palo Alto, CA)
- …we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned ... devastating diseases. This position will report to the VP, Regulatory Affairs and ideally be based in...share risks and achievements with Submission team, sub-teams, and senior management Requirements + Advanced degree (Master's or PhD)… more
- Otsuka America Pharmaceutical Inc. (Bismarck, ND)
- …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
- Fresenius Medical Center (Waltham, MA)
- …(Advanced degree such as a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred. + **Experience:** + 12+ years ... portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...of experience in regulatory affairs , focusing on regulatory … more
