- 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
- Fresenius Medical Center (Waltham, MA)
- **POSITION FEATURES:** This is a remote position with 25% travel **PURPOSE AND SCOPE:** Manages a field team of regulatory compliance employees and provides ... existing trends and new initiatives related to state and federal regulatory activities. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Maintains current/high level… 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
- Danaher Corporation (Boston, MA)
- …reimagine healthcare, one diagnosis at a time. You will be a part of the CCIA Clinical Affairs team and report to the Senior Manager Clinical Affairs who is ... tools that address the world's biggest health challenges. The Clinical Affairs Manager for Beckman Coulter Diagnostics is responsible for directly managing… more
- Edwards Lifesciences (Boston, MA)
- …and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to ... with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize… more
- Merck (Boston, MA)
- …as needed. + Works in partnership with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ functional ... **Job Description** With support of Sr CRA/CRA and/or CRA Manager, acts as primary...inputs on site selection and validation activities. + Performs remote and on-site monitoring & oversight activities using various… 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 Pharmaceuticals- Small Molecule where you will...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… 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
- Danaher Corporation (Boston, MA)
- …wide range of functional areas including Legal, IP, Finance, Product Development, Regulatory Affairs , Operations, Sales & Marketing, Program Management, and ... Strategic and Business Development team and will be fully remote . At IDT, we are one global team. We...of contact, working closely with internal team members and senior leaders, and OI counterparts to manage and advance… 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