Regulatory specialist

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b Title: Regulatory Specialist

Job Description

As a Regulatory Specialist, you will be responsible for processing all initial regulatory documents for submission to Pharmaceutical Sponsors and Institutional Review Boards (IRB). You will also prepare and process required regulatory documentation through the IRB, CTSRMC, FDA, and other applicable regulatory review committees. This role involves working with pharmaceutical companies, contract research organizations (CROs), the NCI, and the FDA.

Responsibilities

• Process initial regulatory documents for submission to Pharmaceutical Sponsors and IRB.
• Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA, and applicable regulatory review committees.
• Prepare and process regulatory documentation for pharmaceutical companies, CROs, the NCI, and the FDA.
  
  

Essential Skills

• Experience submitting to the IRB a minimum of 10 times.
• Bachelor's Degree with 2 to 5 years of experience or equivalent combination of education and experience.
• 3 years of relevant experience in an academic regulatory environment.
• IND/IDE/Clinical Trial Application experience.
• Knowledge and experience with FDA Clinical Trial regulations and guidance.
• Strong writing skills.
• Ability to review and edit policies.
• Ability to work in a team environment and independently.
  
  

Additional Skills & Qualifications

• Experience with regulatory submission, document review, and compliance.
• Knowledge of regulatory affairs and regulatory documents.
• Experience with audits and regulatory compliance.
  
  

Work Environment

This position offers a unique working environment within the city of Philadelphia. The role is 100% remote, with the requirement to reside in NJ, PA, or DE. Our Client provides an urban campus setting with easy access to educational, cultural, and recreational activities. Benefits include tuition reimbursement, a shutdown between Christmas and New Year's Eve, great healthcare, flexible working hours, and paid holidays. The first few days may require equipment pick-up.

Job Type & Location

This is a Contract to Hire position based out of Philadelphia, PA.

Pay and Benefits

The pay range for this position is $28.00 - $31.25/hr.

Requirements

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
  
  

Workplace Type

This is a hybrid position in Philadelphia,PA.

Application Deadline

This position is anticipated to close on Nov 18, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.

If you have questions about this posting, please contact [email protected]