- 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)
- …pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners with internal stakeholders and external CRO ... to the best of my knowledge. **Job Description** The Regulatory Affairs-Labeling, Associate Director is responsible for...partners such as Global Regulatory Compliance, Global Labeling,… 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 (Boston, MA)
- …technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… 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
- Sumitomo Pharma (Boston, MA)
- …experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based ... in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position… 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 (Boston, MA)
- …or a related specialty, disease mechanisms and plasma derived/related therapies + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in plasma ... is true to the best of my knowledge. **Job Description** ** Senior Medical Director , Clinical Sciences** **Cambridge, MA** **Hybrid** **_OBJECTIVES/PURPOSE_**… 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
- Merck (Boston, MA)
- …monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be responsible for** + Evaluating pre-clinical ... **Job Description** Our company is a global health care leader with a diversified portfolio...dedicated colleagues while developing and expanding your career. **The Senior Director ( Senior Principal Scientist)**… 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
- Norstella (Boston, MA)
- Sales Director , Regulatory Company: Citeline Location: Remote, United States Date Posted: Dec 20, 2024 Employment Type: Full Time Job ID: R-799 **Description** ... drug treatments, medical devices and what's new in the regulatory and commercial landscape. Relying on us to deliver...biotechnology and healthcare service providers, including the top 10 global pharma and CROs. Now, Citeline is proud to… more
- Fujifilm (Boston, MA)
- **Overview** The Senior Director , Value Stream is a senior role anchored in the Marketing team reporting into the VP of Marketing. In this role, you are the ... shares our passion, drive, and energy - what we call Genki. Join us as a Senior Director , Marketing - Value Stream and commit your life's work to impacting where… 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
- 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