<p>Job Title: Senior Regulatory SpecialistJob Description</p> <p>As a Senior Regulatory Specialist, you will be responsible for processing all initial regulatory documents for submission to Pharmaceutical Sponsors and Institutional Review Boards (IRB). You will prepare and process all necessary regulatory documentation through various bodies including the IRB, CTSRMC, FDA, and applicable regulatory review committees. Furthermore, you will ensure the preparation and submission of required regulatory documentation to pharmaceutical companies, contract research organizations (CROs), the NCI, and the FDA.</p> <p>Responsibilities</p> <ul> <li>Process initial regulatory documents for submission to Pharmaceutical Sponsors and IRB. </li><li>Prepare and process regulatory documentation through IRB, CTSRMC, FDA, and other regulatory review committees. </li><li>Submit required regulatory documentation to pharmaceutical companies, CROs, NCI, and FDA. </li></ul> <p>Essential Skills</p> <ul> <li>Experience with IRB submissions (minimum of 10 times). </li><li>Bachelor's Degree and 4 years of experience or equivalent combination. </li><li>3 years relevant experience in an academic regulatory environment. </li><li>Experience with IND/IDE/Clinical Trial Applications. </li><li>Knowledge of FDA Clinical Trial regulations and guidance. </li><li>Strong writing skills. </li><li>Ability to review and edit policies. </li><li>Capability to work both independently and in a team environment. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Experience in regulatory affairs and compliance. </li><li>Familiarity with GCP, document review, and clinical research. </li></ul> <p>Work Environment</p> <p>This position offers a unique working environment within the vibrant city of Philadelphia, located on a beautiful urban campus. The role is 100% remote, with the requirement to reside in NJ, PA, or DE. Enjoy the lively cultural offerings and historical landmarks of Philadelphia, while benefiting from flexible work hours, paid holidays, and great benefits such as tuition reimbursement and comprehensive healthcare.</p> <p>Job Type & Location</p> <p>This is a Contract position based out of Philadelphia, PA.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $35.00 - $42.00/hr.</p> <p>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)</p> <p>Workplace Type</p> <p>This is a hybrid position in Philadelphia,PA.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Mar 13, 2026.</p> <p>About Actalent</p> <p>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.</p> <p>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.</p> <p>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 actalentaccommodation@actalentservices.com for other accommodation options.</p>