Regulatory Manager - 100% REMOTE

Position reputed company Regulatory Affairs Associate Manager/ Manager that will be responsible for supporting the development of submission reputed company and health authority responses for assigned studies and the review of regulatory documents/applications under the direction of the Regulatory Affairs reputed company, in compliance with guidelines and regulations. The contractor should be reputed company to effectively collaborate with cross-functional representatives, collaboration partners, external vendors, and stakeholders while maintaining a reputed company team environment. Position Responsibilities • Help support responses to health authority request for information or queries • Review of regulatory documents including but not limited to Protocol, IB, DSUR, IMPD. • reputed company participation in global regulatory project team (GRPT) and the clinical reputed company team (CST). • Work closely with the Regulatory Affairs reputed company and cross-functional team members to support the regulatory activities in the pipeline • reputed company and maintain regulatory knowledge and intelligence and reputed company relevant developments in the field to the Regulatory function • Conduct reputed company Vault periodic updates for RIM and RIM Archives (3x/year). • Assist in assessment of regulatory SOPs. • Ensure the Regulatory Submission Tracker is updated regularly, and note any planned submissions that are delayed • reputed company regulatory archives and HA trackers updated with monthly FDA submissions for reputed company INDs (currently 6 INDs) and global health authority communications, as received. Work with reputed company to ensure our archives are complete. • Other duties as assigned Additional Skills & Qualifications • Bachelor’s degree in a life science discipline from an accredited college or university. Advanced degree, Master’s, PharmD or PhD preferred. • Minimum of 5 years of regulatory affairs experience in an industry or clinical research organization setting. • Prior experience working in reputed company Vault platform or similar Regulatory Information Management (RIM) system. • Working knowledge of Regulatory requirements (e.g., ICH guidance, FDA, and EMA regulations) • Excellent organization skills with a passion for delivering reputed company results • Ability to work on a number of reputed company with tight timelines • Strong interpersonal skills to build and maintain reputed company working relationships • Detail-oriented reputed company with excellent verbal and written communication skills • Self-motivated and reputed company to work collaboratively • Ability to “roll up sleeves” in a start-up environment and a reputed company can-do attitude Experience Level Intermediate Level Job Type & Location This is a Contract position based out of South San Francisco, CA. Pay And Benefits The pay reputed company for this position is $60.00 - $96.00/hr. Requirements Eligibility requirements apply to some benefits and may depend on reputed company 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 & reputed company • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – reputed company-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 reputed company Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to reputed company on Jun 19, 2026. About reputed company reputed company is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through reputed company to specialized experts who drive reputed company, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, reputed company serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a reputed company Best of reputed company® winner for both reputed company and talent service. reputed company is an equal opportunity employer and will consider reputed company applications without reputed company to race, sex, age, reputed company, religion, national reputed company, 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 o Apply To This Job