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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

Regulatory Specialist C

Job Profile Title

Clinical Research Regulatory Specialist C

Job Description Summary

Regulatory Affairs as a field is concerned with ensuring that clinical research is conducted in a safe and legally compliant manner. Regulatory Affairs staff are often the interface between PIs, product manufacturers (including internal at Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff assist in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA-regulated products, including drugs, medical devices, nutritional products and related materials. Regulatory Affairs Specialists must understand the applicable regulations and the roles and responsibilities of sponsors, vendors, clinical researchers, and government officials.

Regulatory Affairs Specialist C will lead the coordination of unit research, including but not limited to Phase I-IV clinical trials. The Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. Regulatory applications may include new study submissions, pre-IND/Pre-IDE submissions, annual reports, amendments, adverse events, and reportable events. They will independently prepare and process all required regulatory documentation for Sponsor Oversight and independent DSMB or Medical Director assessment, as well as organize and maintain all regulatory affairs documentation/Trial Master files (TMF) as required. The Regulatory Affairs Specialist C is expected to resolve regulatory and data queries as required, and lead the conduct of initiation, oversight, and close-out activities related to the conduct of the research by vendors. They will lead study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist C is expected to lead the development of unit guidance/process documents, including work tools, and contribute to the development/maintenance of study-specific case report forms for FDA reporting, as well as provide direct regulatory/compliance guidance. The Regulatory Affairs Specialist C will serve as a mentor and/or trainer to more junior members of the regulatory research team/study team. Additional duties relevant to regulatory affairs as assigned.

The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols that are Investigator Initiated. The Regulatory Affairs Specialist C authors and conducts regulatory assessments of core documents (protocols, Informed Consents, investigator brochure, etc), and is responsible for leading and drafting IND briefing books and Q-submissions, new IND/IDE applications, sponsor reports, and facilitates all communications with the reviewing entities (including FDA and other federal/state/local agencies, per application). The Regulatory Affairs Specialist C will be aware of intellectual property and assist in the management, per Penn COI Policy. They will also be aware of agreements with outside parties to ensure appropriate Sponsor Oversight. The Regulatory Affairs Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for submission and any data reports, and advises on and ensures appropriate oversight of Sponsor vendors.

The Regulatory Affairs Specialist C reviews relevant safety information, obtains feedback from other appropriate parties, and identifies potential impacts to other protocols/staff. Additionally, the Regulatory Affairs Specialist C monitors regulatory news related to assigned activities, and translates into operational changes, as needed. The Regulatory Affairs Specialist C assists in creating new operating procedures and work instructions, supports orientation and training of new staff, provides regulatory training to others, and advises faculty on translation of research from bench to bedside. The Regulatory Affairs Specialist C helps create new tools (I.e., procedures, work instructions, templates). This individual communicates independently at all levels and ensures audit/inspection readiness of assigned projects. The Regulatory Affairs Specialist C would review complex exemption requests (protocols that may include products other than drugs/devices).

Job Description

The Regulatory Affairs Specialist C will lead the coordination of unit research, including but not limited to Phase I-IV clinical trials. The Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. Regulatory applications may include new study submissions, pre-IND/Pre-IDE submissions, annual reports, amendments, adverse events, and reportable events. They will independently prepare and process all required regulatory documentation for Sponsor Oversight and independent DSMB or Medical Director assessment, as well as organize and maintain all regulatory affairs documentation/Trial Master files (TMF) as required. The Regulatory Affairs Specialist C is expected to resolve regulatory and data queries as required, and lead the conduct of initiation, oversight, and close-out activities related to the conduct of the research by vendors. They will lead study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist C is expected to lead the development of unit guidance/process documents, including work tools, and contribute to the development/maintenance of study-specific case report forms for FDA reporting, as well as provide direct regulatory/compliance guidance. The Regulatory Affairs Specialist C will serve as a mentor and/or trainer to more junior members of the regulatory research team/study team. Additional duties relevant to regulatory affairs as assigned.

The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols that are Investigator Initiated. The Regulatory Affairs Specialist C authors and conducts regulatory assessments of core documents (protocols, Informed Consents, investigator brochure, etc), and is responsible for leading and drafting IND briefing books and Q-submissions, new IND/IDE applications, sponsor reports, and facilitates all communications with the reviewing entities (including FDA and other federal/state/local agencies, per application). The Regulatory Affairs Specialist C will be aware of intellectual property and assist in the management, per Penn COI Policy. They will also be aware of agreements with outside parties to ensure appropriate Sponsor Oversight. The Regulatory Affairs Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for submission and any data reports, and advises on and ensures appropriate oversight of Sponsor vendors.

The Regulatory Affairs Specialist C reviews relevant safety information, obtains feedback from other appropriate parties, and identifies potential impacts to other protocols/staff. Additionally, the Regulatory Affairs Specialist C monitors regulatory news related to assigned activities, and translates into operational changes, as needed. The Regulatory Affairs Specialist C assists in creating new operating procedures and work instructions, supports orientation and training of new staff, provides regulatory training to others, and advises faculty on translation of research from bench to bedside. The Regulatory Affairs Specialist C helps create new tools (I.e., procedures, work instructions, templates). This individual communicates independently at all levels and ensures audit/inspection readiness of assigned projects. The Regulatory Affairs Specialist C would review complex exemption requests (protocols that may include products other than drugs/devices).

Job Responsibilities

+ Regulatory Affairs Specialist C will lead the coordination of unit research, including but not limited to Phase I-IV clinical trials. The Regulatory Affairs Specialist C will, independently prepare and process all regulatory documentation/applications for the FDA and requisite review committees. Regulatory applications may include new study submissions, pre-IND/Pre-IDE submissions, annual reports, amendments, adverse events, and reportable events. They will independently prepare and process all required regulatory documentation for Sponsor Oversight and independent DSMB or Medical Director assessment, as well as organize and maintain all regulatory affairs documentation/Trial Master files (TMF) as required. The Regulatory Affairs Specialist C is expected to resolve regulatory and data queries as required, and lead the conduct of initiation, oversight, and close-out activities related to the conduct of the research by vendors. They will lead study team meetings, research team meetings, and ongoing protocol training/compliance meetings. The Regulatory Affairs Specialist C is expected to lead the development of unit guidance/process documents, including work tools, and contribute to the development/maintenance of study-specific case report forms for FDA reporting, as well as provide direct regulatory/compliance guidance.

+ The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols that are Investigator Initiated. The Regulatory Affairs Specialist C authors and conducts regulatory assessments of core documents (protocols, Informed Consents, investigator brochure, etc), and is responsible for leading and drafting IND briefing books and Q-submissions, new IND/IDE applications, sponsor reports, and facilitates all communications with the reviewing entities (including FDA and other federal/state/local agencies, per application). The Regulatory Affairs Specialist C will be aware of intellectual property and assist in the management, per Penn COI Policy. They will also be aware of agreements with outside parties to ensure appropriate Sponsor Oversight. The Regulatory Affairs Specialist C, prepares submissions to the FDA in CTD or eCOPY format, conducts quality reviews of all regulatory documents for submission and any data reports, and advises on and ensures appropriate oversight of Sponsor vendors .

+ The Regulatory Affairs Specialist C reviews relevant safety information, obtains feedback from other appropriate parties, and identifies potential impacts to other protocols/staff. Additionally, the Regulatory Affairs Specialist C monitors regulatory news related to assigned activities, and translates into operational changes, as needed. The Regulatory Affairs Specialist C assists in creating new operating procedures and work instructions, supports orientation and training of new staff, provides regulatory training to others, and advises faculty on translation of research from bench to bedside. The Regulatory Affairs Specialist C helps create new tools (I.e., procedures, work instructions, templates). This individual communicates independently at all levels and ensures audit/inspection readiness of assigned projects. The Regulatory Affairs Specialist C would review complex exemption requests (protocols that may include products other than drugs/devices).

+ The Regulatory Affairs Specialist C will serve as a mentor and/or trainer to more junior members of the regulatory research team/study team.

Qualifications

Bachelor's degree and 5 to 7 years of experience or equivalent combination of education and experience is required. Associated research credentialing (ACRP, RAC, CCRP, CIP, etc.) preferred.

The successful candidate must have effective problem solving and critical tinking abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; thorough and demonstrated knowledge FDA and ICH. Prior education or experience with IND/IDE/Expanded Access Applications, drug development process, medical writing, and clinical trial operations required. Knowledge of appropriate submission mechanisms to different FDA centers (paper, email, NextGen Portal, Electronic Submission Gateway (ESG)) required; knowledge of at least one electronic submission pathway strongly preferred.

The successful candidate must be self-driven with heightened attention to detail. Candidates must desire to work in a fast-paced environment with competing priorities. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth. Candidates should desire to mentor/foster the growth of peers and have experience training peers in a research setting. Candidates must have a high level of general computing ability.

Intermediate/expert level of function in all of the Microsoft Office applications, as well as, applications for team interconnectivity such as Slack, Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience publishing and working with web-based e-regulatory document management systems such as Veeva Systems products, etc. is a plus.

Working Conditions:

Note: Working conditions (hybrid) are based on the needs of the hiring unit.

Resume and cover letter required with application

Targeted Pay Range: $77,920- $85,907

This Targeted Pay Range is only applicable to this job posting. All 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 grade profile.

Job Location - City, State

Philadelphia, Pennsylvania

Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.

Note: Working conditions (hybrid) are based on the needs of the hiring unit.

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. The University of Pennsylvania 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.

Department / School

Perelman School of Medicine

Pay Range

$74,500.00 - $85,000.00 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, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

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.

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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay

The University of Pennsylvania’s special character is reflected in the wide variety of backgrounds, experiences, and perspectives of the Penn community. We seek talented faculty and staff who will constitute a vibrant community and help create an educational and working environment that best supports the University’s commitment to excellence in teaching, research, and scholarship. 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.