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
...Page Counseling Chapter & Page Counseling is a neuroaffirming, trauma-informed therapy practice dedicated to supporting... ...About the Role We are seeking an Independent Licensed Therapist (LPC, LCSW, or LMFT)to join our Arizona-based team as a1099 contractor...
...Job Title: Social Media Marketing Manager About US OXYENERGY,a rapidly expanding DTC supplement brand with its U.S. branch based in Costa Mesa, CA, is on a mission to craft science-backed, content-native wellness products that strike a chord with the next generation...
...Review & Campaign Management) to oversee and evaluate large-scale influencer campaigns with a... ...with marketing managers and organic social teams to align campaign execution with strategy... ...years in influencer marketing and social media marketing management for a notable brand...
Company Description At Golden Shift, we believe that people's core is shaped by their habits and need for connection. We specialize in creating personable experiences that bridge clients and the public through experiential marketing. Our goal is to seamlessly blend client...
...quality and efficiencies Additional duties may be assigned as deemed necessary by management Qualifications Education: ~ Culinary degree and/or cook certification is preferred Work Experience: At least 1 year of experience cooking in a high volume...