- Philips (Cambridge, MA)
- …on time. + Your skills include extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical ... **Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)** The...proactive, strategic relationships with external stakeholders (notified Bodies, US FDA , Competent Authorities, etc.) to ensure that requirements are… more
- Beth Israel Lahey Health (Boston, MA)
- …to the FDA . + Preparation and submission of annual reports to the FDA ; submission of regulatory documents to NIH/OBA, local bio safety committees on oncology ... work experience required. + Must demonstrate good understanding of FDA , cooperative group, NCI and OHRP regulatory ...of FDA , cooperative group, NCI and OHRP regulatory guidelines. + Must maintain confidential and sensitive information,… more
- Danaher Corporation (Boston, MA)
- …or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA and EU regulatory requirements for Companion Diagnostics (CDx) devices. ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory strategy… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …documents for SRC and IRB review and approval + Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious ... appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, maintains and… more
- Sumitomo Pharma (Boston, MA)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Sanofi Group (Cambridge, MA)
- …legal issues (focusing on antitrust matters, potential litigations and promotional matters, FDA / regulatory issues and fraud and abuse) as well as proposed ... furthers the company's strategic goals while effectively managing legal and regulatory risks and upholding the company's integrity and reputation. Additionally, the… more
- Tecomet (Woburn, MA)
- …the training initiatives and document control and records to ensure compliance to FDA , Global Regulatory bodies and ISO requirements. Training includes but is ... and records to ensure documentation procedures are maintained based on FDA /ISO and Corporate standards and regulations. **ESSENTIAL FUNCTIONS:** + Coordinates the… more
- IQVIA (Boston, MA)
- …to make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. ... from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability… more
- Cardinal Health (Boston, MA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct...Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may… more
- System One (Devens, MA)
- …technical field (entry-level to 2+ years' experience) + Strong understanding of GMP and FDA regulatory requirements + High level of safety awareness in an ... timely, and cost-effective production of pharmaceutical products that meet quality and regulatory standards. + Operate in an aseptic environment while fully gowned… more