- 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
- 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
- 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
- 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
- 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
- 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
- Sumitomo Pharma (Boston, MA)
- …. **Job Overview** The Senior Director of ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...a Quality Management System in full compliance with all regulatory requirements. + Ensure the development of QA systems… more
- Lilly (Boston, MA)
- …for our partners and patients. **Purpose of the Role:** The Senior /Executive Director [commensurate with experience], ExploR&D Translational Medicine incumbent ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...GCP + Review and assist in the preparation of regulatory documents (IND, CTA, IMPD, IB, DSURs, etc.) and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …an entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Director , Global Health Economics & Market Access is part of Health ... Economics & Market Access (HEMA) function and reports directly to Executive Director , Global Health Economics & Market Access. In this role the incumbent will be… more