- Fresenius Medical Center (Waltham, MA)
- …be fully remote . **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- J&J Family of Companies (Boston, MA)
- Senior Regulatory Affairs Specialist - 2406193618W **Description** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory ... has a proven track record for growth, integrity and innovation. The Senior Regulatory Affairs Specialist will be responsible for developing strategies to… more
- Beth Israel Lahey Health (Boston, MA)
- …+ Bachelor's degree in Life Science or related field required; Master's degree in Regulatory Affairs preferred. + Minimum of 3-5 years related work experience ... 32 **Work Shift:** Rotating (United States of America) The Sr . Regulatory Specialist supports regulatory ...Center (BIDMC). The position is flexible in terms of remote versus onsite work. A part-time opportunity is available.… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Manager, Regulatory Affairs Project Management and Strategic Planning ... through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global ...around the world. This position is currently classified as " remote " in accordance with Takeda's Hybrid and Remote… more
- Merck (Boston, MA)
- **Job Description** The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs ... model to maintain best-in-industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for: + Directing and… more
- Orchard Therapeutics (Boston, MA)
- Reporting to: Sr . Director, Medical Affairs Location: United States, Boston, MA Job Summary The Medical Information Scientist, Medical Affairs will be ... operations teams - Cross-functional teams (Patient Advocacy, Diagnostics, Clinical Development, Regulatory - Global internal teams (Boston, London, remote ) -… more
- Takeda Pharmaceuticals (Boston, MA)
- …alignment for other medium and/or high complexity products. Interface with Senior Management Cross-Functional Team (GLOC) + Coordinates the process to obtain ... labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) and facilitates discussions to ensure… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... **Job Description** The ** Senior Clinical Director ( Sr . Principal Scientist)**...pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior … more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global), in early and ... ** Regulatory Strategist** + Location: Cambridge, MA + Remote Work: Hybrid + Job Type: Full Time **About...regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed. + May lead Health Authority… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA - CMC Pharmaceuticals- Small Molecule where...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… more
- Amgen (Cambridge, MA)
- …peers across Amgen's internal network (eg, Process Development, Manufacturing, Quality, Regulatory Affairs ) and external suppliers, to ensure uninterrupted ... alongside other innovative, driven professionals in this meaningful role. **Process Development Senior Scientist** **Live** **What you will do** Let's do this! Let's… more
- Bristol Myers Squibb (Boston, MA)
- …child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. **\#LI- Remote , # BMSNEURO** If you come across a role that ... . Reporting into the Medical Value Liaison Field Director, the Senior Medical Value Liaison (MVL)/Executive MVL is a field-based role focused… more
- Takeda Pharmaceuticals (Lexington, MA)
- …in Lexington, MA with the following requirements: Bachelor's degree in Clinical, Regulatory Affairs , Pharmacy, or related field or foreign academic equivalent ... vulnerable points in the PV domain. Up to 10% travel required. Up to 100% remote work allowed from anywhere in the US Full time. $195,458 - $223,200 per year.… more
- Harvard University (Cambridge, MA)
- …around the world conducting research at the intersection of science and international affairs . + Advise and direct senior fellows, research fellows, and visiting ... emerging technologies, research and development of new technologies, and international affairs Additional Qualifications and Skills: + Exceptional writing skills and… more
- Takeda Pharmaceuticals (Boston, MA)
- …and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) + In alignment with TAU/MPD Labeling Lead, ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) driving… more
- Children's Hospital Boston (Boston, MA)
- …role will serve as the primary point of contact for legal affairs at Franciscan Children's and other affiliated organizations, providing strategic legal guidance ... and risk management to address legal and regulatory issues and optimize operational alignment and compliance with...compliance with the OGC. The position will report to senior leadership at the OGC with a matrixed reporting… more
- AbbVie (Cambridge, MA)
- …of drug development, such as Discovery, Preclinical Development, Clinical Development, or Regulatory Affairs . Must possess solid foundation of generally accepted ... assessments of individual partnering opportunities to therapeutic area leadership and senior governance committees as well as contributing to Immunology and BD… more