Regulatory Affairs Specialist

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

📋 Description

• Prepare and submit Part I and/or Part II applications in compliance with the EU CTR, as well as other applications developed internally or externally.

• Ensure that regulatory documentation adheres to relevant regulations and guidelines while meeting contractual deadlines.

• Lead assigned projects focused on regulatory activities that facilitate the initiation of clinical trials.

• Compile regulatory documents, CTA packages, and submissions for designated countries.

• Oversee regulatory timelines and deadlines for CTIS submissions, including EU, APAC, and North America submissions.

• Review regulatory documents and submissions crafted by subcontractors, partner CROs, and regulatory vendors prior to CTIS submission.

• Serve as the main point of contact for sponsors, subcontractors, and project management teams regarding study-related regulatory submissions.

• Prepare or evaluate country-specific Patient Information Sheet/Informed Consent Form documents.

• Prepare or assess study-specific regulatory-form templates.

• Manage translation requests with vendors.

• Provide regulatory support and guidance on local requirements, EU submission strategies, and technical issues.

• Stay informed about EU CTR and country-specific requirements within the EU/EEA.

• Maintain the regulatory intelligence database.

• Participate in kick-off meetings, audits, and other project-related discussions.

⛳️ Requirements

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

• A minimum of 2-3 years of clinical research experience in regulatory affairs within a CRO or Pharma setting in Romania is required.

• Experience with initial CTA submissions is essential.

• A background in a sponsor-facing role is advantageous.

• Previous experience with CTIS is a plus.

• Practical experience in preparing, reviewing, and submitting regulatory documentation.

• Strong understanding of applicable EU regional and national regulatory guidelines.

• In-depth knowledge of GCP and ICH standards.

• Proficiency in English with exceptional oral and written communication skills is required.

• Additional language skills are a benefit.

• Excellent organizational and communication skills with a keen attention to detail.

• Ability to manage personal workload, prioritize various tasks, and perform under pressure.

• Adaptable and comfortable working in a multitasking environment.

• Adhere to established timelines, expectations, priorities, and objectives.

• Must be legally authorized to work in Romania.

🏝️ Benefits

• Permanent full-time position.

• Flexible working hours.

• Vacation entitlement.

• Remote work opportunity.

• Continuous learning and development opportunities.

• Attractive prospects for career advancement.

• Accommodations available during the recruitment and selection process for applicants with disabilities, upon request.