- 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
- Merck (Boston, MA)
- **Job Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented ... drive our strategic priorities. **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs Liaison...product labeling and obtain shortest time to approval by global regulatory agencies. You will independently manage… more
- Merck (Boston, MA)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... product labeling and obtain shortest time to approval by global regulatory agencies. + Reports to Associate... agencies. + Reports to Associate Vice President, Executive Director , or Senior Director in… 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
- Takeda Pharmaceuticals (Boston, MA)
- … regulatory guidance on Human Factors to product teams in line with global regulatory strategies + Develops strategies, tools and trainings to develop the ... with line management + Supports and/ or leads assigned device-related aspects of global regulatory submissions (eg, Core Dossiers, INDs, CTAs, BLAs, MAAs,… 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
- 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 (Providence, RI)
- …+ 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
- 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 (Providence, RI)
- …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
- Fujifilm (Providence, RI)
- …who shares our passion, drive, and energy - what we call Genki. Join us as a Senior Director in Business Strategy - Value Straem and commit your life's work to ... ambition, cater to an actionableKojoXstrategy, and set the strategic goals. As the Senior Director , youare responsible for delivering on the financial MTP/LTP… more
- Takeda Pharmaceuticals (Boston, MA)
- …company that will inspire you and empower you to shine? Join us as an Executive Director , Global Program Leader (GPL) in our Cambridge office. At Takeda, we are ... to simultaneously driving regulatory approval as well as product launch and global patient access + have the ability to partner with all functions to drive,… more
- Sanofi Group (Cambridge, MA)
- ** Senior Clinical Research Director ** **About the Job** We are an innovative global healthcare company with one purpose: to chase the miracles of science to ... you thought was possible. Ready to get started? The Senior Clinical Research Director (Sr CRD) is...for research projects + Represents his/her project at key regulatory agency meetings as the medical spokesperson for the… more
- The Brattle Group (Boston, MA)
- …a privately held, global economics consulting firm, is looking for a ** Senior Director of Marketing and Business Development** to join our **Boston, MA, ... a critical member of the firm's leadership team. The Senior Director will be responsible for shaping...execute that strategy while monitoring success. + Expand Brattle's global brand through innovative initiatives for different markets, legal… more