- Jazz Pharmaceuticals (Philadelphia, PA)
- …more information. Brief Description: The Associate Director position, Regulatory Affairs Global CMC is responsible for establishing global ... regulatory CMC Strategies for commercial and development projects in line...Director will have a strategic role in driving CMC Regulatory Strategies across multi-disciplinary teams ,… more
- Programmable Medicine Operatin (Redwood City, CA)
- …meetings with Clinical Operations, Clinical, Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible for drug substance and drug product and ... technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to...participation in the annual bonus program. At the Associate Director level, the salary range for this position is… 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
- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …as follows: + Independently develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned ... strategy. + Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… more
- Boehringer Ingelheim (Duluth, GA)
- …marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical ... + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately ... **Overview** The Director , CMC provides leadership for the...Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA… more
- Sumitomo Pharma (Lincoln, NE)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of… more
- Sumitomo Pharma (Boise, ID)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… 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
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …mindset and is recognized as a trusted partner and subject matter expert in regulatory affairs . Your expertise spans global regulatory filing strategies, WHO ... and other foundation operational resources. + Experience in health product regulatory affairs , from research and clinical development to post-authorization… more
- Lilly (Indianapolis, IN)
- …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
- Orchard Therapeutics (Boston, MA)
- …closely collaborate with the assigned US Regulatory lead, their peers in Europe, the Regulatory CMC team and the VP of Regulatory Science, to ensure a ... discipline preferred. . At least 15 years experience in Regulatory Affairs in the Biotech environment, spanning...technical development of gene or cell-based therapies and associated regulatory CMC activities is not requested. .… more
- Takeda Pharmaceuticals (Boston, MA)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs . Advanced understanding in DMPK, ... Provides strategic scientific leadership and program management for multiple global CMC development teams dealing with complex development programs that require… 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...and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols… more
- Sanofi Group (Cambridge, MA)
- …products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham,...Research and Development. Sanofi's global regulatory affairs (GRA) function is comprised of… more
- Organon & Co. (Jersey City, NJ)
- …development programs with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, Manufacturing ... and Controls ( CMC ), medical affairs and business development. Non-Clinical Safety Assessment Representative is...Author or review the non-clinical, early clinical development or CMC documentation to support regulatory submissions to… more
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