- AbbVie (North Chicago, IL)
- …. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- Actalent (Grand Rapids, MI)
- Job Title: Quality Assurance Associate Job Description The Regulatory Affairs Specialist plays a crucial role in overseeing regulatory affairs ... 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
- CSL Behring (King Of Prussia, PA)
- …(PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . *Applies the CSL Leadership Capabilities - Build Bridges,… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Otsuka America Pharmaceutical Inc. (Salem, OR)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... ** Associate Director, Small Molecule Analytical Development** + Lead...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- Sanofi Group (Framingham, MA)
- …Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the ... **Job Title:** GRA Device Lead ( Associate Director) **Location** : Morristown, NJ/ Cambridge, MA/...creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country … more
- Sanofi Group (Morristown, NJ)
- …Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the ... **Job Title:** GRA Device Lead ( Associate Director) **Location:** Cambridge, MA/ Morristown, NJ **About...creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country … more
- Sanofi Group (Cambridge, MA)
- …Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the ... creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country ...Regulatory Health Authorities, and others. As GRA Device Associate in the GRA Device Digital and Diagnostic team… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Key Responsibilities** **Process Development & Optimization** + Partner with Regulatory Affairs and cross-functional stakeholders to design, refine, ... **Location:** Remote **Department:** Regulatory Information Management (RIM) / Regulatory Operations **Position Summary** The Associate Director, Process… more
- AbbVie (North Chicago, IL)
- …to use their broad understanding of Product Development, Manufacturing, Quality and Regulatory Affairs to translate the business objectives into actionable ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The ME&C Associate Director is a global program management expert responsible for managing… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization ... DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director) - Global Manufacturing Science GMSci Drug Product (DP), you will… more
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