University of Pennsylvania DIRECTOR, REGULATORY AFFAIRS in Philadelphia, Pennsylvania

DIRECTOR, REGULATORY AFFAIRS 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.

Bookmark this Posting | Print Preview | Apply for this Job

Posting Details

Posting Details

Reference Number 40-27790

Posted Job Title DIRECTOR, REGULATORY AFFAIRS

School Name Perelman School of Medicine

Org DM-Gene Therapy Program

Posted to the Web 06/22/2018

Posted Job/Salary Grade 029

Employment Type Exempt

Hours N/A

Position Type Full Time

Position Schedule 8am-5pm

Months 12

Position Length Contingent Upon Funding

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 Gene Therapy Program (GTP) and Orphan Disease Center (ODC) are entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases. The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the ‘go-to’ organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing. Orphan diseases represent a collection of disorders that afflict fewer than 200,000 individuals for any single disease type, yet there are more than 7,000 distinct orphan diseases. The goal of the Orphan Disease Center is to address these growing needs through continued collaboration and partnership, identifying and providing funding sources, and by providing technological and educational resources to academic researchers, bioetch and pharmaceutical companies alike, to foster therapeutic development and innovative research initiatives. We are currently on the hunt for a Director, Regulatory Affairs (DRA) to navigate researcher teams through the pre-IND and IND filing process for Phase I/II human clinical trials and beyond supporting programs within GTP and ODC. This position reports to the Executive Director of Regulatory Affairs and Compliance within GTP and ODC. As the DRA, you will provide support to GTP with the primary focus being working with collaboration/partnered where the External Sponsor is the IND holder to develop and implement robust global regulatory affairs strategy, including expedited pathways for novel therapeutics in humans that emerge from the R&D activities. You will partner with the Regulatory Writer, Regulatory Operations, and other supporting staff within GTP to provide guidance and strategy for all regulatory documents. Acting as the Subject Matter Expert for topics related to Regulatory Affairs, you will participate in multidisciplinary project team meetings within GTP and ODC, as well as, those arranged by the Office of Clinical Research. The ability to influence and successfully negotiate a mutually agreed upon strategy and approach for these programs is an important attribute. You will monitor current and proposed regulatory, scientific, and pertinent legal issues globally, and perform competitive intelligence to provide an assessment of the impact on product development and IND compliance. In addition, the DRA will provide support to ODC to assist with the development of natural history and registry studies that may be used to support registration for rare and ultra-rare orphan diseases.Joining GTP and ODC offers professionals the unique opportunity of directly affecting research and discoveries that could one day lead to cures.

Qualifications

Master’s degree and at least 5 to 7 years of experience working in a regulatory capacity in the biotechnology or pharmaceutical industry or an equivalent combination of education and experience required.Preferred candidates will have experience working as a lead in Regulatory Affairs for regulatory strategy for IND submissionsPreferred candidates will have experience with biologics submissions.Ability to interact effectively with external business partners and regulatory agenciesDemonstrated excellence in leadership with ability to influence people in a complex, changing environmentStrong strategic skills in creativity and effectiveness in identifying and addressing major strategic challenges Excellent verbal and writing skills with the ability to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders Skilled in conflict resolution; fostering open communication with attention to listening and facilitating discussion Strong negotiating skills with a creative solution-oriented focus.Ability to prioritize and handle multiple project priorities

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/35652

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).


  • 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


  • 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


  • 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

  • Resume

Optional Documents

  • Cover Letter