- Chiesi (Boston, MA)
- Manager , Regulatory Affairs Operations, Rare Diseases Date: Jan 10, 2025 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, ... Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Boston,...(Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and… more
- ThermoFisher Scientific (Waltham, MA)
- …services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational guidance and ... be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs , the incumbent will serve as a member of the LPE… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of...in creative ways. + Responsible for the preparation, compilation, quality check and delivery of regulatory submissions… more
- Sumitomo Pharma (Boston, MA)
- …a dynamic, highly motivated, and experienced individual for the position of **Senior Manager , Medical Affairs Technology and Digital Innovation** . **Job Duties ... affairs content + Implements innovations with respect to quality control mechanisms, supportive systems/databases, efficient inquiry handling workstreams, and… more
- Chemours (Boston, MA)
- …and more modern living depend on Chemours chemistry. Chemours is seeking a **Government Affairs Manager ** to join our growing **Government Affairs ** team in ... on federal public policy issues. + Liaise with Chemours' Functions ( Regulatory Affairs , Communications, Legal, Product Stewardship, Remediation, Sourcing, Tax,… more
- Fresenius Medical Center (Waltham, MA)
- …studies + Experience in project management respectively change control process + Experience in regulatory affairs or in a quality environment, ideally in a ... with the collegial culture of a medium-sized company + Supporting the department in cross-site activities to monitor product quality and regulatory compliance more
- Actalent (Cambridge, MA)
- …PharmD, or PhD preferred. + Minimum of 4 years of experience in regulatory affairs in the pharmaceutical/biotech, including IND activity, global CTAs, DSURs ... Description + Actively represent Regulatory on interdisciplinary teams (eg CMC Teams, Program...generate and refine the product development strategy. + Lead quality portions of global clinical trial applications including the… more
- Cardinal Health (Boston, MA)
- …liaison with Strategic Sourcing, Process Engineering, Design Quality , R&D, Medical Affairs , Quality Compliance and Governance, Regulatory , and other ... policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Supplier Quality is responsible for… more
- Integra LifeSciences (Boston, MA)
- …Coordinates with cross functional leaders in teams such as IS, R&D, Regulatory Affairs , and Operations, to ensure specific quality metrics are met. + Reports ... document storage, and record retention as defined in the Quality Management System (QMS). The DCT Manager ...support all training and documentation requirements adhering to all regulatory requirements for all geographies in which products are… more
- ICON Clinical Research (Boston, MA)
- …progression through design phases. + Coordinate with cross-functional teams, including R&D, Regulatory Affairs , Quality Assurance, and Manufacturing, to ... our mission to shape the future of clinical development. ** Quality Manager , DESIGN CONTROLS:** **On-Site in Cambridge,...medical device regulatory process in collaboration with Regulatory Affairs and providing essential support during… more
- Microsoft Corporation (Boston, MA)
- …Security's programs are aligned and partner closely with governance owners, including Privacy Regulatory Affairs and Corporate External Legal Affairs Front ... critical priorities for our customers in a world awash in digital threats, regulatory scrutiny, and estate complexity. Microsoft Security aspires to make the world a… more
- Cardinal Health (Boston, MA)
- …Reporting technology, Controlled Substance Ordering System (CSOS) platforms support & governance + Quality & Regulatory Affairs (QRA) technology (eg, Federal ... LRCGQ IT is accountable for all technology solutions for the Legal, Regulatory Compliance, Government Relations, & Quality (LRCGQ) organization. The team… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Experience in an academic institution is preferred + Must have expert knowledge of regulatory affairs , research ethics and the responsible conduct of research. + ... **Division of Population Sciences** is seeking a **Senior Research Project Manager ** to oversee a portfolio of research testing behavioral interventions designed… more
- Santander US (Boston, MA)
- Branch Operations Manager , Charlestown, MA Boston, United States of America USA Job Function Description: Responsible for the administration and day-to-day ... procedures and federal and state regulations. May participate in community affairs to enhance the company's visibility and discover new business opportunities.… more
- Integra LifeSciences (Boston, MA)
- …from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs . + Project Management aimed to evaluate, analyze, ... to help improve outcomes. **SUMMARY** This position reports to the Plant Manager and is responsible for manufacturing engineering at the Integra Tissue Technologies… more
- AbbVie (Boston, MA)
- …team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs , and Medical Writing. Safety Statisticians ... is seeking an experienced statistician to join our growing Safety Statistics team. The Senior Manager in the Safety Statistics Group will be a member of one or more… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …biologics, cell therapies, and other drug modalities. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and ... you to shape your future. Join us as a Manager of Statistics at our Cambridge, MA office, where...are addressed. + Communicate internal and external resource and quality issues that may impact deliverables or timelines of… more
- Abbott (Westford, MA)
- …teams, including manufacturing, quality assurance, research and development, and regulatory affairs , to address customer feedback and enhance product ... help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with...in Westford, MA, currently has an opportunity for a ** Manager , Engineering (Sustaining).** **THIS IS AN ONSITE DAILY ROLE.**… 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
- AbbVie (Boston, MA)
- …internal departments including Agency Partners, Marketing functions, Market Research, Legal, Regulatory , Medical Affairs , Office of Ethics and Compliance, and ... + New Jersey + Pennsylvania + New York The Immunology Regional Marketing Manager (RMM) will work closely with multiple AbbVie cross-functional teams to ensure… more