Regulatory Affairs Associate

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

📋 Description

• Assist in the preparation, tracking, and coordination of submissions to the Ethics Committee and Regulatory Authority.

• Gather and compile necessary documentation for EC and RA submissions.

• Monitor submission timelines and maintain regulatory trackers and databases.

• Aid in the initial applications, amendments, and notifications under supervision.

• Collaborate with IRB/IEC and internal teams to obtain required documentation.

• Review and format documents to ensure consistency and completeness.

• Modify country-specific informed consent forms based on master templates.

• Coordinate translation requests and oversee external vendor deliverables.

• Submit documents to the Trial Master File and engage in TMF reconciliation activities.

• Execute document archiving, status reporting, and follow up with sites or vendors.

• Assist in the review and submission of SUSARs as dictated by study scope.

• Remain updated on fundamental regulatory guidelines relevant to assigned countries.

• Participate in internal meetings and training sessions.

⛳️ Requirements

• Bachelor’s degree (or equivalent) in a scientific field.

• 0-2 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, and/or CRO sectors.

• Familiarity with preparing and submitting IRB/IEC packages and/or CTAs.

• Knowledge of relevant regional/national regulatory guidelines and IRB/IEC regulations is a plus.

• Proficient in Microsoft Office Suite.

• Strong command of Microsoft Office Suite (Word, Excel, Outlook).

• Fluency in English (both oral and written).

• Proficiency in additional languages is beneficial.

• Basic understanding of clinical trial processes and regulatory requirements is advantageous.

• Excellent attention to detail and organizational abilities.

• Capability to manage multiple priorities and adhere to deadlines in a fast-paced setting.

• Eagerness to learn and develop regulatory knowledge under supervision.

• Must possess legal authorization to work in Romania.

🏝️ Benefits

• Permanent full-time employment.

• Flexible working hours.

• Vacation time.

• Remote work opportunity.

• Continuous learning and development.

• Competitive opportunities for advancement.