Sr. Regulatory Affairs Specialist
6-month contract-to-hire
Philadelphia, PA (some hybrid flexibility)
ASAP start
POSITION 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 assigned
CREDENTIALS: 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
...Weekend PM (6:30pm to 6:30am, Friday, Saturday, Sunday; work 36 hours receive 40 hours of pay). Responsibilities Quality checks done by weight, measurement, and visual inspections Document results and tests accurately and timely Communicate quality variances...
...assist in the planning and execution of Cleveland area events. Area Events include Gala, Walk, and TopGolf Event. At the end of this internship, the Events Intern will have working knowledge of key event skills, including developing event timelines, planning processes, and...
...96. The town is located near the headwaters of the Yockanookany River, a tributary of the Pearl River. Also, nearby is the Tombigbee National... ...abundance of recreational activities including hiking, biking, boating, and camping. The city of , home of Mississippi State...
...Immediate: Infor XA Techno-Functional Analyst (Full-Time, Direct Hire) Location: Remote, with travel to the NY region as required Were looking for an Infor XA techno-functional analyst whos not just great with users and business processes but also understands...
Clinical Laboratory Supervisor SQ Annual Salary: $81,900 - $106,920 Join California Correctional Health Care Services (CCHCS) as a Clinical Laboratory Supervisor! We are a team of correctional, reentry, and rehabilitation experts who are embarking on a first-of-...