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
.../7 availability, our team is dedicated to meeting the needs of businesses around the clock. Role Description This is a full-time, hybrid location Sales Manager role based in Trenton, NJ and Stockertown, PA. Experience with Mechanical, Electrical, HVAC/R and/or...
...We are seeking candidates that are interested in part-time administrative work. You will be responsible for providing exceptional customer service by interacting with customers and staff, managing office supplies, and assisting with various administrative tasks. If you...
...pink whale is all about. Key Responsibilities: Graphic & Print Design Design and develop graphic artwork for men's & womens... ...Profound understanding of apparel print techniques, including screen printing, digital printing, embroidery and various appliques...
...Assistant Director, Inpatient Services (Hospice) High Point, NC A respected nonprofit hospice organization in High Point is seeking... ...Responsibilities: Provide daily leadership and supervision for inpatient nursing and support staff Support referrals, admissions, and...
...Company Overview Amantine is a French-inspired online womens boutique known for romantic silhouettes, thoughtful detailing, and timeless femininity. We design and curate collections that evoke beauty, confidence, and effortless elegance. Were entering a significant...