Associate Director Regulatory Affairs (Immune Health Institute)

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. 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 Large Employers in 2023.

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.

Posted Job Title
Associate Director Regulatory Affairs (Immune Health Institute)

Job Profile Title
Associate Director, Clinical Research Regulatory

Job Description Summary
he Associate Director of Regulatory Affairs will oversee regulatory strategy and compliance for clinical research initiatives within the Penn Colton Center for Autoimmunity, operating under the Institute for Immunology & Immune Health (I3H). Reporting to the Director for Strategic Alliances and Operations, this position will be instrumental in shaping and implementing regulatory frameworks that support innovative, translational research while ensuring compliance with all applicable regulations and institutional requirements. Key responsibilities include anticipating regulatory changes, planning for organizational growth across Penn, and liaising with regulatory groups across the Perelman School of Medicine, the University of Pennsylvania Health System, and federal government agencies.

Job Description

Strategic Leadership and Regulatory Oversight

Serve as the primary authority on regulatory affairs matters, overseeing regulatory strategy and compliance across the Colton Center's and the broader I3H portfolio

Establish and maintain Standard Operating Procedures (SOPs) for regulatory programs, ensuring adherence to University of Pennsylvania and all applicable regulatory requirements

Lead regulatory strategy development for Colton Moonshot program, including protocol development, case report forms, and source document tools

Drive strategic planning for clinical research regulatory operations while anticipating and adapting to regulatory changes

Stakeholder Engagement and Partnerships

Serve as key departmental representative in collaborations with internal regulatory groups, including Penn's IRB, Office of Clinical Research (OCR), and other oversight committees

Manage relationships with external entities including pharmaceutical companies, CROs, regulatory agencies (e.g FDA, EMA, MHRA, etc.) and research networks

Foster partnerships across departments, centers, and disciplines to facilitate clinical trial conduct and regulatory compliance

Lead preparation and representation for regulatory audits by FDA, EMA, and other health authorities

Operational Excellence and Compliance Management

• Oversee regulatory submissions to the IRB and all applicable review committees across the research portfolio
  
• Direct the organization and maintenance of regulatory documentation and investigator site files (ISF)
  
• Work collaboratively with research teams to identify resource requirements, forecast logistical issues, and ensure smooth protocol activation
  
• Track, analyze, and report trial characteristics, accrual information, and audit findings to senior leadership, including risk assessment and corrective actions
  

Program Development and Process Improvement

• Facilitate ongoing improvement of clinical trial compliance and quality assurance through communication of audit results and compliance guidelines
  
• Identify and implement updates to document storage, retention, and destruction policies
  
• Lead resolution of regulatory and data queries through collaboration with auditors, business units, investigators, and research partners
  
• Evaluate regulatory staff performance and identify areas for improvement
  

Team Leadership and Compliance Culture

• Provide strategic direction, management, mentorship, and oversight for regulatory operations team
  
• Participate in study team meetings, disease site group meetings, and protocol training in a leadership capacity
  
• Facilitate knowledge sharing and best practices across the University
  
• Drive the development and implementation of new policies and procedures to enhance regulatory compliance
  

Qualifications

• Bachelors degree and 7-10 years of experience in regulatory affairs or an equivalent combination of education and experience is required. Master's degree preferred. Experience in academic
  
  medical centers or research institutions.
  
• Demonstrated expertise in IRB processes
  
• Strong understanding of clinical research operations and GCP requirements
  
• Proven track record of successful interaction with regulatory authorities
  
• Experience with multi-site clinical trials and research programs
  
• Excellence in strategic planning and program development
  
• Outstanding communication and interpersonal skills
  
• Demonstrated leadership ability and experience managing teams
  

Position is contingent upon continued funding.

Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$109,433.00 - $130,000.00 Annual Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and

the pay range assigned to the job profile.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements
Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.

University Benefits

• 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/Biomedical-Research-Building-2/Associate-Director-Regulatory-Affairs--Immune-Health-Institute-_JR00103603-1









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About University of Pennsylvania

Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.

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