Regulatory Affairs Manager
- University of Pennsylvania
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. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Employers By State in 2021.
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.
COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.
Posted Job Title
Regulatory Affairs Manager
Job Profile Title
Regulatory Affairs Specialist Senior
Job Description Summary
The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 14 Research Teams that support disease/discipline specific cancer programs within the ACC. Contingent upon funding.
Reporting to the Associate Director for Regulatory Affairs (AD-RA) for the Abramson Cancer Center (ACC) Clinical Research Unit (CRU), the Regulatory Affairs Manager will serve as a lead for the Regulatory Affairs Study Start Up Specialists, Ongoing Review Specialists, and Office Support Staff in day to day regulatory and compliance issues. The Regulatory Affairs Manager will directly train, manage, and supervise the CRU Regulatory Affairs Office staff; including Regulatory Affairs Specialists, Regulatory Administrative Specialists, and Research Assistants. The Regulatory Affairs Manager will develop and maintain work instructions to support the daily operations of the Regulatory Office ensuring consistency and accuracy across the staff and Research Teams. The Regulatory Affairs Manager will be responsible to delegate staff assignments, track workload intensity, quality of work product, and deadlines to ensure timely and appropriate regulatory submissions and compliance for ACC CRU clinical trials, as well as, work in conjunction with the AD-RA to anticipate and plan for changes in operational resource requirements essential for ensuring adherence to local, state and federal regulatory requirements.
The Regulatory Affairs Manager will work collaboratively with internal regulatory groups including the University of Pennsylvania's Institutional Review Board (IRB), ACC Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), the Data Safety & Monitoring Committee (DSMC), the Department of Operations, Compliance & Monitoring (DOCM), and the Office of Clinical Research (OCR); as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and the NCI Cooperative/Clinical Network Groups in the conduct of clinical trials. The candidate must have a thorough knowledge of ICH-GCP regulations and a comprehensive understanding of clinical trial processes and the conduct of clinical research studies.
The Regulatory Affairs Manager will serve as a resource for the ACC CRU Physician-Investigators and clinical research staff on regulatory affairs matters in the study start up and ongoing review processes. The Regulatory Affairs Manager will facilitate day to day regulatory submissions to the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. He/she will participate in initiation and close-out study visits. He/she will participate as needed in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings.
This position is intended to be largely remote. Candidate must agree to use a remote workspace that is conducive to working, free of hazards and other dangers to people and equipment. Abramson Cancer Center, Clinical Research Unit strongly recommends the candidate set up a separate area. Equipment should be placed where it is adequately supported. The candidate remains obligated to comply with all University rules, policies, practices and instructions that would apply if the candidate were working on the premises of the University. The candidate agrees to ensure arrangements are made for dependent care and confirms non-work related interests will not compete with work requirements during the designated regular work hours. The candidate will be responsible for determining any tax implications of maintaining the remote workspace. The candidate will be responsible for complying with any and all local township codes, rules, regulations, and zoning ordinances which could affect the ability to use the designated remote workspace.
The minimum of a Bachelor's degree (in a relevant discipline, biological sciences preferred) and 5-7 years of experience directly related to clinical research regulatory oversight; or an equivalent combination of education and experience required. At least 2-3 years of management experience in a hospital academic medical setting or pharmaceutical experience with principle responsibilities related to regulatory affairs operations. Oncology experience preferred. At minimum, 2 years of Good Clinical Practices (GCP) related experience required; thorough knowledge of GCP, and relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines. Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision. Outstanding organizational skills and the ability to function in a team environment are required. Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; a clear attitude of customer service; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution.
The Regulatory Affairs Manager will facilitate training, directly manage, supervise and train the CRU Regulatory Affairs Office staff; including Regulatory Affairs Specialists, Regulatory Administrative Specialists, and Research Assistants. (
The Regulatory Affairs Manager will develop and maintain work instructions to support the daily operations of the Regulatory start up and ongoing review process ensuring consistency and accuracy across the team.
The Regulatory Affairs Manager will be responsible to delegate staff assignments and track workload intensity and deadlines to ensure timely and appropriate regulatory reporting and compliance for ACC CRU clinical trials
The Regulatory Affairs Manager will work collaboratively with internal regulatory groups including the University of Pennsylvania's Institutional Review Board (IRB), ACC Clinical Trials Scientific Review and Monitoring Committee (CTSRMC), the Data Safety & Monitoring Committee (DSMC), the Department of Operations, Compliance & Monitoring (DOCM), and the Office of Clinical Research (OCR); as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and the NCI Cooperative/Clinical Network Groups in the conduct of clinical trials.
The Regulatory Affairs Manager will facilitate day to day regulatory submissions to the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events.
Perform additional duties as assigned
Job Location - City, State
Department / School
Perelman School of Medicine
$59,703.00 - $113,435.00
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.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
- Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
- Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
- Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
- Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
- Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
- Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
- Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
- University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
- Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
- Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
- Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
- Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Regulatory-Affairs-Manager_JR00041623-2
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