- Takeda Pharmaceuticals (Boston, MA)
- …Description** Takeda Development Center Americas, Inc. is seeking a Manager , Global Regulatory Affairs CMC in Cambridge, MA with the following ... requirements: Master's degree in Regulatory Affairs or related field plus 2 years of related experience. Prior experience must include: Develop the regulatory… more
- Teva Pharmaceuticals (West Chester, PA)
- …for maintaining and updating CMC sections of submissions for assigned products. As Manager CMC Regulatory Affairs you will also be responsible ... Manager , CMC Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 19380 Company: Teva Pharmaceuticals Job Id:… more
- BeiGene (Emeryville, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **the** **job:** . Lead, develop and implement small molecule CMC regulatory strategies as well as authoring...is a plus. + Demonstrated leadership as a people manager . + Experience in authoring complex technical documents, CTD… more
- Regeneron Pharmaceuticals (Troy, NY)
- …for program-specific discussions, connect the dots across IOPS, proactively identify CMC regulatory issues and suggest appropriate strategies to mitigate ... **In this role, a typical day might include the following:** * Support CMC /Combination product development activities from a regulatory standpoint during early… more
- Merck (Rahway, NJ)
- **Job Description** **Job Description:** As part of the Global Regulatory Affairs & Clinical Safety (GRACS) CMC Operations team, the CMC Operations Sr. ... regulatory information and supporting business processes and systems. Exposure to regulatory affairs either through direct experience, or via a role in… more
- Ascendis Pharma (Palo Alto, CA)
- …perspectives to all aspects of the business, from drug development to marketing. The Manager , Regulatory Affairs will be responsible for supporting and ... Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key Responsibilities + Responsible for.... Key Responsibilities + Responsible for strategic and operational regulatory input and support for cross functional ( CMC… more
- Lauridsen Group Inc. (Ankeny, IA)
- The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international ... develop and implement regulatory strategies. The Senior Manager of Regulatory Affairs is...ensure alignment with overarching PHB business strategies. + Provide regulatory leadership with expertise in CMC and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …the Senior Director, Commercial Regulatory Affairs , in collaboration with Head, Regulatory Affairs and CMC -RA, will review and assess all commercial ... hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the development...and non-promotional materials. + Collaborates closely with the PMRC Manager and other members to quickly resolve issues that… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Senior Manager of Regional Regulatory Affairs ? This position is located in our ... regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC...GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide… more
- AbbVie (Madison, NJ)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Senior Manager , Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison ... product(s) with multiple driver indications within a Therapeutic Area and support the Manager , Global Regulatory Lead (GRL), Associate Director, or Director, in… more
- J&J Family of Companies (Titusville, NJ)
- …or process excellence is preferred + Experience with clinical development and regulatory affairs is preferred Other: + Project Management Professional (PMP) ... Pharmaceutical Development Program Manager - 2406180821W **Description** Janssen Research & Development, LLC, a division of Johnson & Johnson's Family of Companies,… more
- LA Care Health Plan (Los Angeles, CA)
- …(OMT) Online Monitoring Tool (OMT) by Gorman) will also be updated and reported to Regulatory Affairs and Compliance (RAC) for support of CMS regulatory ... Financial Compliance Data Manager II Job Category: Accounting/Finance Department: Financial Compliance...to the Claims department to collect Medicare/ Cal MediConnect ( CMC ), Organization Determination, Appeals & Grievances (ODAG) data from… more
- WuXi AppTec (Middletown, DE)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… more
- GAP Solutions Inc (Bethesda, MD)
- …is required with at least Three (3) - Five (5) years of experience in regulatory affairs and project management related to the approval of vaccines and ... Position Objective: Provide services as a Scientific Program Manager in support of the overall functions of...Clinical Quality Management System (CQMS). + Thorough understanding of regulatory affairs or vaccine development experience gained… 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
- Gilead Sciences, Inc. (Foster City, CA)
- …with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs , Quality Control and Manufacturing Operations ... supporting process chemistry and formulation development, and generating data for regulatory submissions. The Principal Scientist will be a technical leader in… more
- Editas Medicine (Cambridge, MA)
- …significant clinical components and implications. + Collaborate closely with Non-clinical, Regulatory , Clinical Operations, CMC and Biometrics to ensure tight ... the clinical pipeline. The incumbent is expected to have a strong clinical, regulatory and scientific foundation, and will work closely with the cross functional… more
- AbbVie (Irvine, CA)
- …brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , etc., and ... Asset Plan and PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. . Ensures that the AST… more