- Takeda Pharmaceuticals (Boston, MA)
- …activities. 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… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA Waltham, MA **About the Job** Are you ready to shape the future of ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a… 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 ... products CMC science and manufacturing processes. + Knowledge of global CMC regulatory requirements and guidelines for reporting post approval changes… more
- Lilly (Indianapolis, IN)
- …need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC technical ... molecules and/or synthetic peptides, proteins or oligonucleotide. + Knowledge of global CMC regulatory requirements and guidelines for reporting post… 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 ... synthetic molecule CMC drug development science(s). + Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and… more
- Merck (Rahway, NJ)
- …Team. This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... This individual will be a senior member of the Regulatory Affairs CMC organization and... Regulatory Affairs Global Regulatory Policy and the Head of CMC … more
- Boehringer Ingelheim (Athens, GA)
- …product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical products in ... Delivers expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
- AbbVie (North Chicago, IL)
- …and company policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product ... CMC on teams such as product development, Global Regulatory Product Teams and Operations brand...initiatives internal to RA CMC . + Represents CMC regulatory affairs on project… more
- Sanofi Group (Framingham, MA)
- …non-viral LNPs), with teams in France, Germany and the USA. Reporting to the head of Global CMC Development, this highly visible role has the potential to make a ... **Job Title:** Global Head, BioAnalytics, CMC Development **Location**...and with other Sanofi functions (eg, Research, Quality Assurance, Regulatory Affairs , Manufacturing & Supply, Business Development).… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement CMC strategies to enable data driven ... shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …or more therapeutic areas covering multiple dosage forms while interacting effectively within Regulatory Affairs and across CMC stakeholder functions, as a ... Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs . This position will require the Fellow… more
- Sumitomo Pharma (Tallahassee, FL)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- ThermoFisher Scientific (Grand Island, NY)
- …Chemistry, or related field; advanced degree preferred + 7 years of experience in CMC regulatory affairs within the pharmaceutical industry + 1+ year ... (GMP) Safety Standards, Office **Job Description** The Sr. Manager, Regulatory Affairs - Drug Support Strategy is...regulatory standards + Provide strategic mentorship on applicable CMC regulatory submissions and support for customers… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Bausch + Lomb (Juneau, AK)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a… more
- Bausch + Lomb (Juneau, AK)
- …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer… more
- Actalent (Grand Rapids, MI)
- Job Title: Quality Assurance Associate Job Description The Regulatory Affairs Specialist plays a crucial role in overseeing regulatory affairs activities ... requirements to stakeholders to ensure compliance. + Provide regulatory CMC support and review client submissions...and maintain SOPs, work instructions, and related documentation for Regulatory Affairs . + Perform Regulatory … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …+ Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and ... balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning,...compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs , Global Regulatory Lead (GRL) ... The GRL builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA- CMC...and regulatory excellence attributes as described in Global Regulatory Affairs white papers.… more
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