Sr. CMC Regulatory Affairs Specialist

Sr. Regulatory Affairs Specialist6-month contract-to-hirePhiladelphia, PA (some hybrid flexibility)ASAP startPOSITION SUMMARY:The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols. The Regulatory Affairs Specialist C reviews and creates core documents (protocols, Informed Consents, investigator brochure, Monitoring Plans, etc) and reports, and is responsible for the preparation of health authority submissions including meetings, new IND/IDE applications, and maintenance for these applications by and facilitating all communications with the reviewing entities (including FDA, IRB, and other federal/state/local agencies, per application). The Regulatory Affairs Specialist C will need to be aware of legal agreements needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, via electronic means, where available and feasible.Support faculty sponsors and OCR Regulatory leadership on topics related to GXP and translational research.DUTIES:15% Reviews and creates core documents (protocol, informed consent, investigator brochure, monitoring plans, etc.) and reports.20% Prepare health authority submissions including meetings, new IND/IDE applications, and maintenance of these applications. Facilitate all communication with reviewing entities.20% Ensure high quality of the research projects assigned and documentation is current and complete.10% Review relevant safety information, obtain feedback from other parties, and identify potential impacts to other protocols/staff.5% Inspection Readiness and facilitate audits of assigned projects.2.5% Aware of legal agreements needed and/or planned and ensures appropriate information is included and addressed.2.5% Assist in creating new operating procedures, work instructions, and templates.5% Monitor regulatory news related to assigned activities, translate into operational changes as needed.10% Provide guidance and training to Penn faculty sponsors and staff.5% Assist OCR Regulatory leadership with metrics and reports as assigned.5% Other duties as assignedCREDENTIALS: Bachelor's degree and 5-7 years research experience required; at least 2 year's regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) are highly recommended or preferred to be completed within 1 year of employment.COMPETENCIES:· Problem-solving and critical thinking abilities· Collaboration.· Communicates effectively (verbal and written).· Scientific knowledge and research design.· Thorough and demonstrated knowledge of Regulatory Framework and GXPs· Initiative and self-driven· Detail oriented.· Strong Organization & Time management.· Flexible and able to multi-task· Intermediate/expert level of function in all of the Microsoft Office applications, as well as applications for team interconnectivity such as Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience working with web-based e-regulatory document management systems such as Veeva Systems products, the Electronic Common Technical Document (eCTD), etc. is a plus.Requirements:-5+ years of CMC regulatory experience-bench science experience-Pharma/biopharma industry experience-familiar with IND/ IDE applications

Created: 2025-03-09