Regulatory Affairs Associate - Romania

Role Overview

The Regulatory Affairs Associate will aid the preparation, monitoring, and coordination of submissions to Ethics Committees and Regulatory Authorities. Working under supervision, the associate will assist the Regulatory Affairs team to ensure clinical trial documentation complies with regulations and expected timelines.

Key Responsibilities

• Compile and prepare required documents for Ethics Committee and Regulatory Authority submissions.
• Help track submission deadlines and maintain updated regulatory trackers and databases.
• Support preparation and submission of initial applications, amendments, and notifications with oversight.
• Coordinate with Institutional Review Boards/Independent Ethics Committees and internal teams to gather necessary paperwork.
• Review, format, and ensure documents are complete and consistent before submission.
• Assist in adjusting country-specific informed consent forms following master templates.
• Manage translation requests and track progress with external vendors.
• Submit documentation to the Trial Master File and contribute to its reconciliation for assigned sections.
• Conduct administrative duties including archiving, status reporting, and follow-up with study sites or vendors as instructed.
• Support regulatory specialists with SUSAR reviews and submissions according to study requirements.
• Maintain familiarity with basic regulatory guidelines of assigned countries.
• Participate in team meetings and training sessions as necessary.

Candidate Requirements

• Bachelor’s degree or equivalent in a scientific field.
• Up to 2 years’ clinical regulatory affairs experience in pharmaceutical, biotech, or CRO contexts; familiarity with IRB/IEC package or clinical trial application submissions preferred.
• Knowledge of regional or national regulatory and IRB/IEC requirements is advantageous.
• Strong proficiency with Microsoft Office, particularly Word, Excel, and Outlook.
• Fluency in English (written and oral) required; additional languages are beneficial.
• Basic understanding of clinical trial methodology and regulatory demands is a plus.
• Excellent attention to detail and organizational skills.
• Ability to manage several priorities efficiently in a fast-paced setting.
• Motivated to learn and grow regulatory knowledge under supervision.

Company and Work Environment

Indero, formerly Innovaderm, is a leading clinical research organization focusing on dermatology and rheumatology trials, boasting over 25 years of experience and a global reach. Our workplace values collaboration, innovation, reliability, and responsiveness, providing a dynamic environment with opportunities for career advancement.

Additional Details and Benefits

• Permanent full-time contract.
• Flexible working hours.
• Paid vacation entitlement.
• Home-based working option.
• Continuous professional development and training.

Equal Opportunity

Indero is committed to equal opportunity employment and will provide reasonable accommodations to applicants with disabilities. Only candidates legally authorized to work in Romania will be considered.