- Astellas Pharma (Westborough, MA)
- ** Regulatory Manager , Regulatory Affairs - CMC (Gene Therapy)** Do you want to be part of an inclusive team that works to develop innovative ... lead or deputy for complex projects/products, requiring advice from manager on complex issues. + Manages technical documents for...for eligible positions + Referral bonus program \#LI-TR1 Category Regulatory Affairs CMC Astellas is… more
- BeiGene (San Mateo, CA)
- **General Description:** + The Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC strategies ... a scientific discipline with minimum 5+ years of experience in a global CMC regulatory affairs position (with expertise in biologics and deep experience in… more
- AbbVie (North Chicago, IL)
- …YouTube and LinkedIn. Job Description The Senior Manager Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and external ... policies and procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams such as the product development,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California **About the role:** The CMC Regulatory Affairs Sr. Manager at Gilead is responsible for providing ... contributes to global process improvements, which have a significant impact for the Regulatory Affairs CMC Department or development matrix teams + Coach and… more
- Pfizer (Kalamazoo, MI)
- …of activities, such as, but not limited to, preparing or authoring CMC regulatory investigational, commercial and post approval submissions, representing the ... help Pfizer develop and implement chemistry, manufacturing and control ( CMC ) regulatory strategies for small and large...is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry… more
- Ascendis Pharma (Palo Alto, CA)
- …to all aspects of the business, from drug development to marketing. The Senior Manager , Regulatory Affairs will be responsible for supporting and developing ... Alto, CA and reports directly to the Head of Regulatory Affairs . Key Responsibilities + Responsible for.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Manager Regulatory Affairs Date: Sep 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 57668 **Who we ... **The opportunity** Teva Pharmaceuticals USA, Inc. is seeking a Regulatory Affairs Manager (Parsippany, NJ)...+ Assessing Change Controls for Chemistry, Manufacturing and Controls ( CMC ); Knowledge of USFDA regulatory guidance's, MAPPs,… more
- West Pharmaceutical Services (Exton, PA)
- …Requisition ID: 66496 Date: Sep 12, 2024 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: **Who We Are:** At West, we're a dedicated ... Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West's global...IEC 62304, ISO 11608), 21 CFR Part 820 and CMC regulatory requirements. + Experience in medical… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …cell therapies, and other drug modalities. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... If so, be empowered to take charge of your future at Takeda. Join us as a Manager of Statistics in our Cambridge, MA office. Here, everyone matters and you will be a… more
- Bausch Health (Bridgewater, NJ)
- …facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC , Graphics, Legal, Quality, ... labeling for accuracy and for other regulatory requirements. + Liaise with Regulatory Affairs members and other cross-functional teams to ensure the accuracy… more
- Takeda Pharmaceuticals (Lexington, MA)
- …with colleagues in Pharmaceutical Sciences, Supply Chain Operations, Quality Assurance and CMC - regulatory Affairs , while serving as an important point ... in development and/or manufacturing. + Experience in the GMP environment, and regulatory affairs . + Experience managing technical capabilities in a global… more
- Rush University Medical Center (Chicago, IL)
- …input to his/her supervisor to identify areas of opportunity within the manager 's scope, escalate risk and resolve barriers. This position will provide direction, ... communicates with Revenue Cycle colleagues, study teams, patients, Office of Research Affairs , IRB, RUMC Compliance, and all partners in the Research Continuum. *… more
- Taiho Oncology (Princeton, NJ)
- …(Clinical Studies, CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs , HEOR, CMC and other related ancillary providers etc.) sourcing ... Sr. Manager , Outsourcing & Vendor Management Princeton, NJ, USA...negotiation, and project award. + Ensures compliance with all regulatory and reporting requirements related to Supplier Diversity and… more
- Novo Nordisk (Lexington, MA)
- …(statistics, pharmacometrics), Research and Early Development, Global Translation, Global Medical Affairs , Global Safety (GS), Bioanalysis, CMC and occasionally ... clinical pharmacology aspects at internal and external meetings with eg regulatory authorities /advisory board meetings / governance boards / investigator meetings… more
- IQVIA (Durham, NC)
- …Associate, CTL&D Specialist + Other Interfaces: Quality and Compliance Manager /Specialist, R&D/Local Operating Company staff (including Medical Affairs ), ... rendered will adhere to applicable Johnson & Johnson SOPs, Wis, policies, local regulatory requirements, etc. + Co-author of the IPPI and review/provide input on all… more
- Takeda Pharmaceuticals (Boston, MA)
- …QUALIFICATIONS/REQUIREMENTS** + Previous drug development experience is preferred (eg Medical Affairs , Clinical Research, Regulatory , CMC , or other ... experience required + 5 to 7 years experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment + Minimum… more