- 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
- Eli Lilly and Company (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
- System One Holdings, LLC (Florham Park, NJ)
- …documents for electronic submissions. Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance, to ... Job Title: Regulatory Operations Senior Publisher - Contractor...met. Ability to work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance… more
- Barrington James (Madison, OH)
- …regulatory interactions. Cross-Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs , Program Management, CMC , and ... Senior Medical Director, Clinical Development (Oncology) Location: US...oversee medical aspects of clinical trials from design to regulatory submission, providing scientific and operational leadership in close… 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
- 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
- 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
- System One (Florham Park, NJ)
- …documents for electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance, to ... Job Title: Regulatory Operations Senior Publisher - Contractor...+ Ability to work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance… 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
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …Society for Quality (ASQ) as a Certified Quality Auditor (CQA) and/or from the Regulatory Affairs Professional Society (RAPS) as a Regulatory Affairs ... guideline on the Common Technical Document (CTD) for pharmaceuticals, and/or regulatory Chemistry, Manufacturing Controls ( CMC ) submission experience. * Detail… more
