Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare, review, compile, and assist in the submission of regulatory documents for designated research IND applications, including initial INDs, annual reports, protocol amendments, information amendments, and safety reports.

• Aid in the preparation of non-emergency use single-patient IND submissions.

• Evaluate investigator regulatory files and site documentation, such as Form FDA 1572s, IRB approvals, and associated documents, ensuring accuracy, completeness, and compliance.

• Contribute to maintaining adherence to applicable regulatory requirements, institutional and departmental policies, FDA regulations and guidance, and GCP guidelines.

• Foster professional growth and development by engaging in seminars, workshops, professional associations, and other educational opportunities to stay updated with regulatory affairs practices.

• Guarantee adherence to relevant regulatory, departmental, and institutional policies and FDA guidance rulings, while ensuring compliance with Good Clinical Practice (GCP) guidelines for research programs.

⛳️ Requirements

• Bachelor’s Degree in a scientific discipline, regulatory affairs, or a related field with a minimum of 3-5 years of experience, or a Master’s/PhD in a scientific discipline, regulatory affairs, or a related field with 0-2 years of experience.

• Experience in regulatory affairs or a related FDA-regulated industry is essential.

• Regulatory Affairs Certification (RAC) or other relevant regulatory certification is preferred.

• Exceptional written, editorial, and verbal communication abilities.

• Strong organizational skills with a proven capacity to manage deadlines, prioritize competing tasks, and handle regulatory deliverables in a fast-paced environment.

• Proficient analytical, critical thinking, proofreading, and document review skills.

• Solid understanding of FDA regulatory requirements and guidance pertaining to INDs.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development