Regulatory Specialist (Remote - US)

This position is posted by Jobgether on behalf of ObjectiveHealth. We are currently looking for a Regulatory Specialist in United States.

Join a dynamic team committed to advancing clinical research and improving patient outcomes through innovative processes and technology. In this role, you'll coordinate regulatory activities across multiple research sites, ensuring documentation compliance, GCP standards, and seamless communication with sponsors and internal teams. This position offers a high-impact opportunity to contribute directly to the quality and efficiency of clinical trials while growing your regulatory expertise in a supportive and fast-paced environment.

Accountabilities:

• Manage and maintain regulatory documentation throughout clinical trial lifecycles, including start-up and ongoing submissions.
• Ensure compliance with IRB protocols, HIPAA, sponsor requirements, and applicable regulatory standards such as GCP, FDA, and ICH guidelines.
• Prepare, submit, and track study-specific regulatory and training documentation, ensuring accuracy and timely updates.
• Maintain up-to-date credentials and documentation for physicians and key personnel, including CVs, licenses, and training records.
• Review and edit Informed Consent Forms for compliance with study protocols and regulatory requirements.
• Collaborate with investigators, research teams, and external sponsors to resolve issues and maintain open communication.
• Participate in audits, monitoring visits, and regulatory inspections, ensuring readiness and compliance.
• Deliver regulatory training to research staff and contribute to continuous process improvement.

• Bachelor’s degree in life sciences, healthcare, or a related field is preferred.
• Minimum of 2 years’ experience in clinical research regulatory affairs or a similar function.
• Solid understanding of FDA regulations, GCP, ICH guidelines, and IRB operations.
• Strong organizational and multitasking skills with keen attention to detail.
• Excellent written and verbal communication abilities.
• Self-starter with the ability to work independently and meet deadlines in a fast-paced environment.
• Legal authorization to work in the US is required (no visa sponsorship available).

• Competitive compensation package with clear pathways for career advancement.
• 401(k) plan with company match.
• Comprehensive health, dental, and vision insurance.
• Health Savings Accounts and Flexible Spending Accounts.
• Short- and long-term disability coverage.
• Generous paid time off and paid holidays.
• Adoption assistance and a variety of voluntary benefit options.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.
When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias—focusing solely on your fit for the role.
Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

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