- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation ... where you will define, develop and lead global strategies to maximize global ...their regional counterparts. **How you will contribute:** + The Senior Director will be responsible for complex… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals ( Senior /Executive Director ) OBJECTIVES/PURPOSE + ... unexpected events. + He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …development plans. As part of the GRA CMC team, you will report to the Senior Director GRA CMC and work cross functionally across the business. **How you ... life-changing therapies to patients worldwide. Join Takeda as a Director GRA CMC where you will independently develop and...- technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Senior Global Medical Director Ophthalmology **Location:** Cambridge, MA **About the Job** In order to pursue Sanofi's purpose of "Chasing the ... exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch first… more
- Olympus Corporation of the Americas (Westborough, MA)
- …additional information, audit responses, etc.). Can serve as a backup to the Global Director Quality Compliance: External Regulatory Communications. Review ... agencies regarding compliance issues. Leads and manages the development of all global regulatory communication processes to include responses external audits,… more
- Takeda Pharmaceuticals (Lexington, MA)
- …FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership related to ... is true to the best of my knowledge. **Job Description** **Associate Director , US Advertising & Promotion Regulatory Review** **Takeda Pharmaceutical**… more
- Novo Nordisk (Lexington, MA)
- …the therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Novel Modalities department Work with the ... About the Department Our East Coast Global Development Hub brings together the best minds...you ready to make a difference? The Position The Senior International Medical Director serves as a… more
- Takeda Pharmaceuticals (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... and empower you to shine? Join us as a Senior Medical Director , Oncology Clinical Science in...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- … Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the process ... patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you will ... Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs -...regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism ... therapies in **programs focused on respiratory disease.** + The Senior Director of Clinical Research will be...seamless transition of the new asset to the Pfizer Global Product Development (GPD) for Ph3 development. **ROLE RESPONSIBILITIES**… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Sanofi Group (Cambridge, MA)
- **Job title** : Senior Director , Marketing Operations NA GTMC **Location:** Bridgewater, NJ or Cambridge, MA (Hybrid role) **About the Job** We are an innovative ... global healthcare company, committed to transforming the lives of...up the decision making. We are seeking an experienced Senior Director of Marketing Operations to join… more
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** ** Senior Manager, US Medical Ad/Promo Regulatory Review** **Takeda Pharmaceutical** ... Exton, PA** **About the role:** Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review...the US Medical team, you will report to the Director , Ad/Promo Regulatory Review. You will be… more
- ICON Clinical Research (Boston, MA)
- Senior Director , Design Control- Cambridge MA- Hybrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to ... fulfil our mission to advance and improve patients' lives. ** Senior Director , Design Control- Cambridge MA- Hybrid**...kit production. + Core understanding of the medical device regulatory process in collaboration with Regulatory Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You ... to the Takeda Safety Board and similar forums. The Senior Medical Director will be a key...submissions, investigational and new drug applications and interactions with regulatory authorities worldwide. + Assists the Global … more
- Bayer (Cambridge, MA)
- ** Senior Director Clinical Pharmacology Lead** The Clinical Pharmacology Lead (CPL) Oncology will bring an extensive experience and knowledge of the Clinical ... labels. **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities for this role Senior Director Clinical Pharmacology Lead are to: + Independently… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …toward departmental initiatives for quality, process and talent development. As an R&D senior director with a program management focus, the Senior ... and software development + Extensive experience in product development to meet global regulatory and standards requirements + Experience with successful … more