Senior Regulatory Affairs Specialist - FSP - EMEA

This is a fully remote position, open to applicants in Bulgaria, +5 more countries.

📋 Description

• Act as the primary lead across multiple countries/projects, delivering regulatory expertise and managing client interactions.

• Assess country-level essential documents for thoroughness, accuracy, and quality in accordance with the study-specific Essential Document Compliance checklist.

• Evaluate site-level essential documents for thoroughness, accuracy, and quality.

• Inform the EDP Submitter via email regarding review results, requested modifications, and corrected documents when deficiencies are found.

• Review amended document packs to confirm that deficiencies have been addressed.

• Relay review results to the SSU Specialist.

• Monitor EDP review details within the relevant data tracking system.

• Stay updated on SOPs, client SOPs/directives, and current regulatory standards.

• Assist in ensuring prompt site activation.

⛳️ Requirements

• Proficient in English (both written and spoken) communication skills, as well as the local language when necessary.

• Strong attention to detail and quality assurance.

• Skills in editing and proofreading.

• Effective interpersonal skills to collaborate successfully within a team setting.

• Competency in computer applications, including Microsoft Word, Excel, and PowerPoint.

• Willingness to learn new technologies.

• Basic organizational, time management, and planning abilities.

• Capacity to develop and adhere to timelines, engage in long-term planning, adapt to shifting priorities, and manage multiple projects.

• Strong negotiation skills.

• Capability to work independently with guidance and exercise sound judgment.

• Bachelor's degree or equivalent experience of at least 2 years.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.