- Lilly (Philadelphia, PA)
- …generation and execution of country specific CMC regulatory strategies + Lead CMC regulatory submissions including overall submission project, ... diagnostic radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing country-specific … more
- Regeneron Pharmaceuticals (Troy, NY)
- …global markets. + Lead the preparation, coordination, and compilation of CMC regulatory submissions for non-US/EU markets in accordance with local ... are seeking a highly motivated and experienced regulatory professional responsible for overseeing CMC aspects of global submissions . This position would focus on… 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)
- …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
- Lilly (Indianapolis, IN)
- …CMC technical knowledge and Regulatory Science expertise to drive Regulatory CMC strategies and develop submissions for marketing authorizations. The ... technical expertise, to strengthen submission or minimize risk. * Reviews and approves CMC documents for global regulatory submissions , including submissions … more
- BeiGene (San Mateo, CA)
- …be responsible for development of strategies, planning, drafting, and managing CMC -related regulatory submissions to meet aggressive timelines. The individual ... assigned projects. + Work collaboratively with cross-functional leads and communicate regulatory CMC strategies for assigned projects. + Lead regulatory risk… more
- Gilead Sciences, Inc. (Foster City, CA)
- …strategies to ensure right first-time approvals of product submissions . + Lead the execution of these global CMC regulatory plans, including overseeing ... position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions , and "right to...Development & Manufacturing (PDM) Project teams. **Job Description:** + Lead CMC regulatory strategy for a single… more
- Lilly (Indianapolis, IN)
- …for cross-functional CMC teams for programs of moderate complexity. + Lead the creation, development, communication and implementation of integrated CMC ... for people around the world. **Position Summary:** The Associate Director, CMC Project Management will provide strategic and operational leadership for… more
- Organon & Co. (Plymouth Meeting, PA)
- …to maintain the quality of scientific, technical and regulatory information within CMC submissions , responses and correspondence. + Identify, communicate, and ... CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to...CMC scientists in the Organon franchise teams. + Lead development and execution of regulatory CMC … more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC submission activities and be responsible for organization of CMC -related documents for regulatory submissions . Actively contribute to organizations ... planned initiatives and projects, lead and manage multiple and simultaneous projects. As part...CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established… more
- AbbVie (North Chicago, IL)
- …Responsibilities + Lead cross-functional S&T product teams and represent the CMC team and/or S&T in interface with S&T leadership, other Operations functions, ... (https://www.tiktok.com/@abbvie) . Job Description Purpose Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline… more
- J&J Family of Companies (Columbus, OH)
- …Authorities under supervision of a senior member of the department. + Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle + ... Associate Director, CMC Regulatory Affairs - 2406221330W **Description** Johnson &...supply chain to ensure continuity of product + May lead selected initiatives within the department + Participates in… more
- AbbVie (North Chicago, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead an experienced team responsible for ... function's capabilities based on emerging modalities and technologies to support future pipeline submissions . + Collaborate with and advise CMC project teams in… more
- AbbVie (South San Francisco, CA)
- …deliverables and help drive drugs substance purification development strategy though program lead assignments in cross-functional CMC teams. This position is an ... Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Biologics CMC Development team at AbbVie in the Bay Area has a long and… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director, CMC Program Lead , Cell Therapies in Cambridge, MA with the ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- Actalent (Boston, MA)
- …to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions , including assembling necessary cross functional teams and ... *Gene therapy experience preverred* Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams (eg… 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
- 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
- OnKure, Inc. (Boulder, CO)
- …support collaborations, audits, and regulatory meetings. Essential Duties and Responsibilities: Lead analytical CMC strategy Develop and execute the analytical ... regulatory CMC strategy and the preparation of global regulatory submissions using clear and accurate source documentation Stay updated on regulatory… 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