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ASSOC DIR REGULATORY AFFAIRS

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Posting Details

Posting Details

Reference Number 40-25947
Posted Job Title ASSOC DIR REGULATORY AFFAIRS
School Name Perelman School of Medicine
Org SM-DN-Office of Clinical Research
Posted to the Web 05/27/2017
Posted Job/Salary Grade 029
Employment Type Exempt
Hours 40.00
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
Duties

The Office of Clinical Research (OCR), Sponsor Support Unit, together with the Perelman School of Medicine (PSOM) is seeking an Associate Director of Regulatory Affairs. This position directs the regulatory aspects of the Cart Cell Therapy program, contributes to all Unit activities, is responsible for the supervision, preparation and critical review of high quality regulatory submissions to the FDA and other global authorities, including INDs, IDEs, and CTAs, amendments, annual reports, and safety reporting, overall planning and direction of regulatory activities, and developing and implementing strategies with the goal of prompt approval of regulatory submissions. This position will work in tandem with the Directors of the Sponsor Support Unit and the Senior Associate Director to provide direct guidance to new and current IND, IDE, and CTA sponsors in the PSOM.

Qualifications

Master’s degree and 5 to 7 years of experience in drug and device development or equivalent combination of education and experience required. Master’s degree in Regulatory Affairs preferred. RAC preferred. Direct experience with the FDA required and some experience with Health Canada and EMA member states required. Possess strong communication, management, and organizational 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/28772

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