- BeiGene (Emeryville, CA)
- **General Description:** + The Senior Manager , Regulatory Affairs CMC , is responsible for developing and implementing global regulatory CMC ... degree. **Experience:** + Minimum 6+ years of experience in a global CMC regulatory affairs position with expertise in biologics and deep experience… more
- Sanofi Group (Bridgewater, NJ)
- **Job title:** Manager , Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager , Global Regulatory Affairs ... Products, Biologics, and Vaccines). This individual is responsible for global regulatory CMC strategies, submission dossiers and approvals, including direct… more
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC Submissions Management in Lexington, MA with ... changing requirements and priorities; develop/maintain strong working relationships with the regulatory CMC team and cross-functional teams, participate on… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …this role, a typical day might include the following:** + Responsible for CMC /CP product development activities to lead the regulatory standpoint during early ... for program-specific discussions, connect the dots across IOPS, proactively identify CMC /CP regulatory issues and develop appropriate strategies to mitigate… 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
- 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
- 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)
- …analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs + Has knowledge of fundamental ... understanding in Clinical Sciences, Regulatory CMC , DMPK, Pharmacology and Toxicology +...in a highly cross-functional team environment + Experienced People manager able to develop other Program Leaders in drug… 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …emerging genetic medicine modalities in collaboration with the PK Subject Matter experts, Regulatory Affairs , and other relevant stakeholders. + Manage team of ... Regeneron is seeking a highly motivated ** Manager , Scientific Writing** to supervise regulatory ...Toxicology, and Pharmacology) as well as select documents supporting CMC and Clinical Pharmacometrics content. **A Typical Day Looks… 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
- 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