- Otsuka America Pharmaceutical Inc. (Augusta, ME)
- …of regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications… more
- BeOne Medicines (Emeryville, CA)
- …taken when recalls or product complaints arise during product lifecycle for the assigned project . + Provide CMC regulatory review for clinical protocols and ... regulatory strategies as well as authoring CTD CMC sections for the assigned project to...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Regeneron Pharmaceuticals (Troy, NY)
- … strategies for the assigned drug/device portfolio. This role involves overseeing regulatory affairs staff, various outside contractors, supporting project teams ... **A typical day might include:** + Oversee the assigned CMC /CP Regulatory Affairs team, driving global ...performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our Cambridge, MA office. As a Senior Manager ... in the design, analysis, and interpretation of Chemicals, Manufacturing, and Controls ( CMC ) study data throughout Pharmaceutical Sciences. We seek an innovative and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …approaches to reduce COGs and strengthen supply reliability. + Collaborate closely with an assigned CMC Project Manager (who will provide you PM support). + ... Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution across functions… more
- Bristol Myers Squibb (Indianapolis, IN)
- …external stakeholders . Review and author technical reports and source documents to support regulatory filing. . Review and author CMC sections for IND/NDA for ... critical to advancing our preclinical development, Chemistry, Manufacturing, and Controls ( CMC ) strategy and ensuring successful technology transfer to clinical and… more
- CSL Behring (King Of Prussia, PA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . + Proactively fosters and promotes effective relationships ... Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure 'One GRA Voice', appropriate...(eg, GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units ... associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external...needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,… more
- Eurofins US Network (Lancaster, PA)
- …substances and products. **Job Description** **Role Overview** The GMP Testing Project Manager is responsible for planning, coordinating, and overseeing ... strategies. + Ensure all deliverables meet client expectations and regulatory requirements. + Prepare and present project ...biologics. + Experience in GMP lab operations, especially in CMC testing. + Proven ability to manage complex projects… more
- Kelly Services (Malvern, PA)
- …other cross-functional departments + Participate in and/or lead cross-functional meetings with CMC and project team representatives and stakeholders + Lead ... ** Project Coordinator** Kelly Services is currently seeking a...of Kelly Services, Inc., is currently seeking a Content Manager for a 12 month + engagement at one… more
- Boehringer Ingelheim (Duluth, GA)
- …stakeholders will vary from USA GI Region, USA CMC , Corporate Affairs or regulatory agencies. + In partnership with RA project team members, helps drives ... initiatives to achieve USA priorities for RA and USA CMC objectives. This role is directly responsible for improving...and responsible for supporting RA leader by reflecting the regulatory submission timing needed for project program.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …or more products and provide strong technical expertise and leadership for regulatory interactions, including authoring CMC content for multi-site products. ... and timely decision-making. + Represent Biologics Product Sciences on cross-functional CMC and project teams and collaborate closely with Pharmaceutical… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing ... of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC , publishing, etc. +… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …You will also represent the drug product process science perspective in regulatory CMC interactions, translating process understanding into clear and defensible ... + Local Technical Services organizations + Global Quality and Regulatory CMC teams + Ensure process knowledge...and/or parenterals). + Demonstrated success as an SME and project leader in a matrix environment, influencing technical decisions… more
- BeOne Medicines (Emeryville, CA)
- …commercial negotiations, defining responsibilities between BeiGene and the CMO. Act as project manager of the contract negotiation with close partnership with ... **General Description:** The Senior Procurement Manager of CMO Category is responsible for establishing,...with contract manufacturers (CMOs) worldwide, Commercial Supply Chain, CMO Project Managers, Alliance Managers, Quality and CMC … more
- Bristol Myers Squibb (Seattle, WA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
- Amgen (Thousand Oaks, CA)
- …partners such as Drug Substance Technologies, Drug Product Technologies, Product Quality, Regulatory CMC , and Supply Chain. The successful candidate will ... improvements, and support method and validation and transfers + Contribute to global regulatory filings by authoring analytical CMC sections and RTQs ensuring… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- … regulatory submissions for OPDC R&D products. Performs quality reviews of CMC sections of regulatory submissions. + Authors and maintains Standard Operating ... The Senior Manager , Global Product Quality - Biologics is responsible...Subsidiaries ensure Compliance with local and global requirements and regulatory requirements. + Interfaces with project teams… more
- Bausch + Lomb (Tampa, FL)
- …structured phase gate processes. + Advanced knowledge of cGMPs and associated CMC regulatory considerations in a pharmaceutical/biotech environment. + Excellent ... the advancement of eye health in the future. **Objectives/Purpose of Job:** The Senior Manager is a member of the Pharma and Lens Care Solutions Technical Services… more
- ICON Clinical Research (Blue Bell, PA)
- …medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). Vendor ... Clinical Drug Supply Manager ICON plc is a world-leading healthcare intelligence...needed. Supports inspection team in preparation for and during regulatory agency inspection. Study Team Interaction + Represents Clinical… more
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