Skip to Main Content

REGULATORY AFFAIRS SPC SR

Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.

If you would like to bookmark this position for later review, click on the Bookmark link. If you would like to print a copy of this position for your records, click on the Print Preview link.

Posting Details

Posting Details

Reference Number 40-26855
Posted Job Title REGULATORY AFFAIRS SPC SR
School Name Perelman School of Medicine
Org SM-DN-Office of Clinical Research
Posted to the Web 09/15/2017
Posted Job/Salary Grade 028
Employment Type Exempt
Hours N/A
Position Type Full Time
Position Schedule 8:30-5:30
Months 12
Position Length Ongoing
Position End Date
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education. http://www.med.upenn.edu/

Duties

The primary responsibility of the Regulatory Affairs Senior Specialist is to serve as the regulatory lead for university held INDs, IDEs, and foreign CTAs. In this role, he/she will provide regulatory leadership, author of FDA submissions, contribute to and review core documents, liaise with the FDA and regulatory authorities, provide project management to sponsor teams and opine on regulatory strategy. In addition, he/she will provide day-to-day regulatory support and contribute to the development of operational processes, that will ensure adherence to government and institutional policies and provide guidance to current and potential Sponsors in Perelman School of Medicine (PSOM).
This position will support potential IND/IDE/CTA Sponsors in offering guidance with FDA and international regulatory authority applications and amendments, processing IND/IDE/CTA exemption requests and will aid with the development and submission of related documents (consent forms, safety monitoring plans, investigator brochures, safety reporting etc).
* Project Management
* Provide regulatory support and guidance to Sponsors and Investigators
* Write and edit Sponsor support tools and SOPs
* Author and coordinate regulatory submissions and applications
* Review IND/IDE/CTA exemption requests
* Conduct Sponsor Training and Workshop training

Qualifications
  • A Bachelor’s Degree and 5-7years relevant experience in clinical regulatory environment, or combination of education and experience required. Masters degree in a science related field is a plus.
    * IND/IDE/Clinical Application experience
    * Knowledge and experience with FDA Clinical Trial regulations and guidance (GMP, GLP, GVP, and GCP)
    * Demonstrated ability to work on projects independently
    * Strong writing skills
Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Quick Link http://jobs.hr.upenn.edu/postings/31323

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Indeed.com
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter