- Unknown (Philadelphia, PA)
- …the ability to manage multiple projects and work effectively under pressure. Experience in FDA regulatory and quality assurance matters is preferred. The ... role requires a professional who is adept at problem-solving, and decision-making, and who can lead continuous improvement initiatives within the legal department. Hiring Manager Title Executive Director, Associate General Counsel Travel Percent Less than 10%… more
- Unknown (Exton, PA)
- …in manufacturing strategy implementation, collaboration with clinical operations and quality assurance for regulatory compliance, and leading manufacturing ... submissions, including BLA preparation, and a history of successful FDA or international regulatory agency inspections are also essential. The role demands a… more
- Unknown (Philadelphia, PA)
- …include overseeing the statistical aspects of regulatory submissions, particularly with the FDA , and ensuring the quality and integrity of data analysis and ... or biotechnology industry, and a proven track record in regulatory submissions. The Senior Director will also be expected...stay current with the latest developments in biostatistics and regulatory guidance, and to have a strong knowledge of… more
- Globus Medical, Inc. (Audubon, PA)
- … Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...conformance to 21 CFR regulations. + Assists with other regulatory matters as requested. + Attends FDA … more
- Sumitomo Pharma (Harrisburg, PA)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct… more
- Dentsply Sirona (York, PA)
- …device industry. + Experience with leading regulatory submissions and managing regulatory projects. + In-depth knowledge of FDA 510(k) and international ... communication skills. + Prior technical writing experience and proven track record with FDA and EU regulatory submissions. + Excellent interpersonal skills. +… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... as CMC regulatory lead on global project teams (Pharmaceutical Development, Quality , Manufacturing, Global Regulatory Strategy). + Assess and provide … more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Philips (New Kensington, PA)
- …right fit if:** + You've acquired a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have ... The Principal Regulatory Affairs Specialist will develop and execute the...EUMDR tech files, and Pre-Sub notifications submitted to the FDA . + Your skills include familiarity with FDA… more
- University of Pennsylvania (Philadelphia, PA)
- …and serve as a key departmental stakeholder representing the department/division related to regulatory audits by the FDA , EMA, other Competent Health Authorities ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more
