- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Takeda Manufacturing USA, Inc. is seeking a CMC Submissions Lead in Cambridge, MA with the following requirements: ... strategy, establish submission structure in electronic common technical document format for CMC Module 3 information; Written and oral communication skills in regard… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA with the following requirements: ... regulatory CMC team and cross-functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently;… more
- Astellas Pharma (Westborough, MA)
- …+ Demonstrated track record for successful Health Authority interactions related to CMC submissions . **Preferred** + S. or Ph.D in Chemistry/Biochemistry, PharmD ... in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls ( CMC ) aspects of regulatory documents and submissions . Responsible for… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. Join Takeda as a Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead where you will establish collaboration ... with members of the team, develop high quality clinical, commercialization and LCM submissions , using proactive regulatory CMC strategies and submit them as… more
- Takeda Pharmaceuticals (Boston, MA)
- …having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred. + ... which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization. + Lead team members… more
- Bausch + Lomb (Boston, MA)
- …**Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and content of CMC dossiers for prescription ... with R&D and Quality organizations to prepare and maintain CMC sections of submissions and respond to...Supply Chain as appropriate in a timely manner. + Lead and drive all CMC submission activities… more
- Astellas Pharma (Westborough, MA)
- …or product and the application. **Essential Job Responsibilities:** + Acts as CMC regulatory lead or deputy for complex projects/products, requiring advice ... regulatory agencies. Assesses scientific data against regulatory requirements and reviews submissions against regulatory strategy. Ensures proper CMC Dossier… more
- Actalent (Boston, MA)
- … CMC strategies to support gene therapy development. Key Responsibilities + Lead global Regulatory CMC strategic guidance and provide tactical support to ... and CMC teams. + Manage regulatory requirements, interactions, and submissions for CMC activities. + Engage in internal Regulatory CMC activities and… more
- Actalent (Boston, MA)
- …to agency questions, and maintenance activities. * Coordinate and drive regulatory CMC submissions , including assembling necessary cross functional teams and ... Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory expertise as a member...to generate and refine the product development strategy. * Lead preparation of high-quality global clinical trial applications in… more
- Takeda Pharmaceuticals (Boston, MA)
- …and right first time + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Human Factors, and ... collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device combination and… more
- Randstad US (Cambridge, MA)
- …GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs. + In collaboration with ... team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Director, Global Reg Affairs Device, PDT in our Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda. ... The Global Regulatory Affairs CMC & Device organization is responsible for global device...of high quality and compliant regulatory device documentation (eg, Q- Submissions , PMAs, De Novo filings, 510(k)s, EU Technical Docs,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …member of External Biologics Supply Operations Team. Represent External Biologics Supply on CMC team. + Lead across multiple projects in a timeline-driven work ... best of my knowledge. **Job Description** **Job Title** : External Technical Services Lead **Location** : Lexington, MA **About the role:** As an External Technical… more
- Takeda Pharmaceuticals (Boston, MA)
- …all major countries + Develop, implement and execute a smart sourcing strategy + Lead global CMC key initiatives and represent Pharmaceutical Science to other ... experience is of advantage + Experience in reviewing and approving analytical-related CMC sections of IND/IMPD and BLA/MAA regulatory submissions . Knowledgeable… more
- Takeda Pharmaceuticals (Boston, MA)
- …any other characteristic protected by law **_Objective / Purpose:_** The Drug Discovery Lead (DDL) serves as a strategic leader within the Oncology Drug Discovery ... that deliver game-changing, highly differentiated, therapeutic opportunities for patients. + Lead and manage multiple drug discovery projects, overseeing the entire… more
- Sanofi Group (Cambridge, MA)
- …possible. Ready to get started? Sanofi is seeking an **Analytical Development Director** to lead the analytical group in our CMC function at Cambridge Crossing ... which is part of the synthetic platform within Global CMC Development. We are striving to become an industry...oral dosage forms at Sanofi's Cambridge Crossing site + Lead the analytical team to provide support for studies… more
- Sanofi Group (Waltham, MA)
- …+ **Align GAD research activities** with clinical trial expectations, including IND submissions , support for CMC (Chemistry, Manufacturing, and Controls), and ... to all, regardless of gender._ **Job title:** Global Antigen Design (GAD) Research Lead bacteriology + _Location: Marcy l'Etoile (69)_ **_About the job_** Are you… more
- Takeda Pharmaceuticals (Boston, MA)
- …right first time. + Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them ... for demonstrating Takeda leadership behaviors + Serves as Drug-Device Combinations US lead for assigned asset programs + In consultation with Platform Regulatory… more
- AbbVie (Waltham, MA)
- …the acceptability and quality of affected product lots. *Author and review relevant CMC sections of submissions and support agency inspections, inquiries and ... achieves projects and area goals. Generate new scientific proposals and lead those efforts. Apply scientific, engineering principles and statistical process… more
- Sanofi Group (Waltham, MA)
- …cycle management. Responsible for regulatory statistical responses and medical journal submissions . + Accountable for deploying CMC vaccines statistical support ... Sanofi Vaccines as the **Director of Non-clinical Biostatistics** where you will lead a team of experts and deploy state-of-the-art statistical designs and analysis… more