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Sports Research

Operations Associate

San Pedro, CA · On-site

Operations Associate 📍 San Pedro, CA 💼 Full-Time | Non-Exempt (W2) Comp Range: 24$ -35$/hr ... You'll collaborate closely with teams across Quality, Regulatory, Supply Chain, Procurement ...

Frontier Cooperative

Operations Associate

Osceola, NE · On-site

An OPERATIONS ASSOCIATE engages in the safe unloading, loading, and storage of grain in the ... regulations. * It is also every employee's responsibility to identify & communicate workplace ...

PYA P C

Trade Operations Associate

Knoxville, TN · On-site

The Trade Operations Associate is responsible for executing and managing trades across client portfolios in accordance with firm strategies, client objectives, and regulatory requirements. This role ...

River Bank

Operations Associate

Stoddard, WI · On-site

Description We invite you to join River Bank as a full-time Operations Associate in Stoddard! That ... banking regulations. * Other duties as assigned. Requirements * High School diploma or GED.

River Bank

Operations Associate

Stoddard, WI · On-site

We invite you to join River Bank as a full-time Operations Associate in Stoddard! That's about 15 ... banking regulations. * Other duties as assigned. Requirements: * High School diploma or GED.

Dutch Farms

Operations Associate

Painesville, OH · On-site

$18/hr

About the Role: Operations Associate As an Operations Associate, you'll play a key role in ... regulation • Sampling and process documentation • Running the hot oil heating system • ...

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Regulatory Operations Associate information

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How much do regulatory operations associate jobs pay per hour?

As of Jul 12, 2026, the average hourly pay for regulatory operations associate in the United States is $26.24, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $30.29 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Regulatory Operations Associate, and why are they important?

To excel as a Regulatory Operations Associate, you generally need a background in life sciences or a related field, strong attention to detail, and experience with regulatory documentation processes. Familiarity with electronic document management systems (EDMS), eCTD publishing tools, and knowledge of regulatory submission standards are typically required. Excellent organizational skills, communication, and the ability to manage multiple deadlines help candidates stand out. These competencies ensure accurate, timely regulatory submissions and compliance, which are critical for product approvals and organizational success.

What are Regulatory Operations Associates?

Regulatory Operations Associates are professionals who support the preparation, submission, and management of documents required by regulatory agencies for product approvals, especially in industries like pharmaceuticals, biotechnology, and medical devices. They ensure that submissions comply with legal and regulatory standards, track submission timelines, and often use specialized software for document management. Their work is crucial for maintaining compliance and facilitating smooth communication between their company and regulatory authorities. Additionally, Regulatory Operations Associates may coordinate with cross-functional teams to gather necessary documentation and maintain up-to-date records.

How does a Regulatory Operations Associate typically collaborate with cross-functional teams within an organization?

Regulatory Operations Associates frequently work alongside regulatory affairs, quality assurance, clinical, and legal teams to ensure that all submissions and documentation comply with industry standards and governmental regulations. They coordinate the collection, formatting, and timely submission of regulatory documents, often acting as a liaison between departments to resolve any discrepancies or gather necessary information. Effective communication and organization are key, as the role requires balancing multiple deadlines and adapting to evolving requirements set by regulatory authorities.

What is the difference between Regulatory Operations Associate vs Regulatory Affairs Specialist?

AspectRegulatory Operations AssociateRegulatory Affairs Specialist
Required CredentialsBachelor's degree, familiarity with regulatory processesBachelor's degree, often with certifications in regulatory affairs
Work EnvironmentSupportive regulatory teams, administrative tasksStrategic planning, compliance management
Employer & Industry UsagePharmaceutical, biotech, healthcare companiesPharmaceutical, medical device, biotech sectors
Common Search & ComparisonYesNo

The Regulatory Operations Associate typically handles administrative and operational support within regulatory teams, focusing on document management and submission processes. In contrast, the Regulatory Affairs Specialist is more involved in strategic compliance, ensuring products meet regulatory standards. Both roles are essential in regulated industries like pharma and biotech, but they differ in scope and responsibilities.

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What job categories do people searching Regulatory Operations Associate jobs look for? The top searched job categories for Regulatory Operations Associate jobs are:
Regulatory Operations Associate jobs near you
Associate Director, Regulatory

Associate Director, Regulatory

The University of Pennsylvania

Philadelphia, PA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 8 days ago

University Of Pennsylvania rating

8.1

Company rating: 8.1 out of 10

Based on 81 frontline employees who took The Breakroom Quiz

134th of 552 rated colleges and universities

Job description

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
Job Profile Title
Associate Director, Clinical Research Regulatory
Job Description Summary
With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the department/division. The Associate Director for Regulatory Affairs assists the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory Office (or Regulatory Program)/reporting regulatory affairs staff, anticipating and planning for changes in the regulations governing clinical research, planning for the regulatory aspects of growth of department/division research activity, and liaising with regulatory groups across the department/division, University, and federal government.
Job Description
Job Responsibilities
  • With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the department/division. The Associate Director for Regulatory Affairs assists the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory Office (or Regulatory Program)/reporting regulatory affairs staff, anticipating and planning for changes in the regulations governing clinical research, planning for the regulatory aspects of growth of department/division research activity, and liaising with regulatory groups across the department/division, University, and federal government.
  • The Associate Director for Regulatory Affairs will directly oversee, train and mentor any reporting Regulatory Affairs Supervisor and/or Regulatory Affairs Specialist A/B/C. In this capacity, the Associate Director for Regulatory Affairs will have oversight of all regulatory staff, including monitoring workload intensity and tracking deadlines to ensure timely and appropriate regulatory reporting and compliance for any/all clinical research conducted within the department/division. The Associate Director for Regulatory Affairs will assist the Director in establishing and maintaining Standard Operating Procedures for the Regulatory Office (or Regulatory Program) to ensure adherence to regulatory requirements of the University of Pennsylvania and all applicable regulatory bodies. In conjunction with any reporting Regulatory Affairs Supervisor, the Associate Director for Regulatory Affairs will evaluate regulatory staff performance and identify areas for improvement.
  • The Associate Director for Regulatory Affairs will serve as the primary point of authority for the Physician-Investigators and clinical research staff on regulatory affairs matters. The Associate Director for Regulatory Affairs will contribute to/assist in the development of training programs for investigators to enhance understand of and compliance with applicable regulations.
  • The Associate Director for Regulatory Affairs will also serve as the key departmental stakeholder representing the department/division when working with internal regulatory groups including the University of Pennsylvania's Institutional Review Board (IRB), the Office of Clinical Research (OCR), and any other ancillary oversight groups; as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and research networks such as the National Cancer Institute Cooperative/Clinical Network Groups in the conduct of clinical trials. They will oversee preparations for and serve as a key departmental stakeholder representing the department/division related to regulatory audits by the FDA, EMA, other Competent Health Authorities and other University Departments.They will assist with the development of investigator-initiated research protocols and development/maintenance of study specific case report forms and source document tools. They will facilitate collaborations in the conduct of clinical trials between other departments, centers, researchers and the supporting department/division, including but not limited to the development of best practices and new policy within the department/division and to be shared collaboratively across the University(opportunities for growth and improvement as discussed with the University of Pennsylvania's Institutional Review Board (IRB), the Office of Clinical Research (OCR) and other ancillary oversight committees).
  • The Associate Director for Regulatory Affairs will work collaboratively with research teams to identify resource requirements for upcoming protocols, forecast logistical issues impacting regulatory compliance, and ensure smooth transition of protocols from regulatory start up to study activation. They will assist the Director with facilitating and tracking the flow of new research studies through the start-up process, by identifying regulatory obstacles to activation, and propose improvements to the process will track, analyze and report to senior leadership department-wide trial characteristics, accrual information and audit/monitoring findings; such reports will include an assessment of trial information, areas of potential risk or roadblocks to success, and potential corrective actions. The Associate Director for Regulatory Affairs will facilitate ongoing improvement of clinical trial compliance and quality assurance through communication of audit results and compliance guidelines.
  • The Associate Director for Regulatory Affairs will have oversight of regulatory submissions to the IRB and all applicable regulatory review committees across the portfolio of research undertaken by the department/division. Regulatory applications may include new study submissions, continuing reviews, amendments, adverse events, and reportable events. They will oversee the organization and maintenance of all regulatory affairs documentation/investigator site files (ISF) as required by regulation across the department/division, including anticipating for and implementing updates to document storage/retention/destruction policies and programs. They will provide leadership to resolve regulatory and data queries through close collaboration with auditors, involved business units, investigators, research teams, and research partners. This may include developing and fostering close partnerships with both internal and external leaders spanning departments, divisions, and disciplines. They will attend initiation, monitoring, audit and close-out study visits as needed in support of department/division staff, goals, and/or to discussion opportunities and growth. They will attend study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings in a leadership capacity.
  • Other duties as assigned.

Qualifications
  • Bachelor's degree and 7-10 years relevant experience, or a combination of education and experience required. Master's degree preferred. ACRP and/or RAC certification required. Expert knowledge of GCP, and relevant regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines required. Knowledge of appropriate submission mechanisms to different FDA centers (paper, email NextGen Portal, Electronic Submission Gateway (ESG)) required. 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.
  • The successful candidate must also have effective problem solving and critical thinking abilities; effective communication and writing skills; be flexible and able to multi-task. Prior education or experience with IND/IDE/Expanded Access Applications, drug development process, medical writing, and clinical trial operations 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. Candidates should desire to mentor/foster the growth of peers and have experience training peers in a research setting. Candidates should welcome constructive criticism, be open to learning new approaches, and committed to continued career/professional growth. 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 working with web-based e-regulatory document management systems such as eFlorence, Veeva Systems products, etc. is a plus.
  • Candidate must have a solid understanding and ability to apply, as well as teach, all skills outlined in the junior level roles

  • Resume and cover letter required with application

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.
Department / School
Perelman School of Medicine
Pay Range
$105,500.00 - $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, 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

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About University of Pennsylvania

Sourced by ZipRecruiter

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.

Industry

Colleges, universities, and professional schools

Company size

10,000+ Employees

Headquarters location

Philadelphia, PA, US

Year founded

1740

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