- ThermoFisher Scientific (Allentown, PA)
- …of legal entities in EMEA. + Prepare, co-ordinate and supervise local regulatory filing submissions , including approvals + Maintain corporate directorship ... appointments, including preparation of associated documentation and reports + Collaborate with internal staff, business teams, legal advisors, auditors, treasury, tax, and external collaborators to support subsidiary formations, capital changes, ownership… more
- University of Pennsylvania (Philadelphia, PA)
- …Research will prepare and process, with minimal supervision , all initial oversight submissions for regulatory documentation through the IRB, FDA and all ... Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision ,… more
- University of Pennsylvania (Philadelphia, PA)
- …supervision. Additional duties include overseeing junior coordinators and independently completing regulatory and IRB submissions . Prior experience with industry ... sponsored collaborators is preferred. These positions are contingent upon funding. Hiring range minimum for this position is $46,500. Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to… more
- Globus Medical, Inc. (Audubon, PA)
- …their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions ... II and class III products. This position entails development of FDA submissions , requires working knowledge of products under review and of relevant regulations… more
- Canon USA & Affiliates (Harrisburg, PA)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... handling, coordination of product recalls, FMI processes, processing electronic submissions and state registrations. **RESPONSIBILITIES** + Remote position, **west… more
- J&J Family of Companies (Spring House, PA)
- …https://www.jnj.com/innovative-medicine We are searching for the best talent for a **Manager, Regulatory Medical Writing** to support one or more of our therapeutic ... areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting...+ If a lead writer for a program/compound (or submissions , indications, or disease areas): act as the primary… more
- University of Pennsylvania (Philadelphia, PA)
- …complex Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components of submissions (eg, institutional forms, ... IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute...Penn is the lead site. + Prepare components of submissions to the IRB (and other entities) and remain… more
- Sumitomo Pharma (Harrisburg, PA)
- …teams. Regulatory Interactions: + Prepare and present clinical data to regulatory agencies (FDA, EMA) during IND submissions , clinical study reports, and ... programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory , Early Clinical Development, Pre-clinical research, Medical Affairs and… more
- Cardinal Health (Harrisburg, PA)
- …knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and approvals), ... action. + Support research to maintain a pulse on product, supplier, regulatory , and market dynamics; understand how industry trends may impact Averon; and… more
- Robert Half Accountemps (Wilkes Barre, PA)
- …and examining account information. * Manage fixed asset accounting and assist with regulatory filings, audits, and tax submissions . * Document and monitor ... and analyzing production data. * Familiarity with fixed asset accounting and regulatory filings. * Ability to reconcile accounts, including bank accounts and… more