Associate Clinical Trials Regulatory Manager – EMEA

This is a fully remote position, open to applicants in Serbia, +4 more states.

📋 Description

• Act as the Clinical Trial Regulatory Manager (CTRM) for intricate clinical trial projects and programs.

• Provide regulatory oversight and strategic direction to both internal and external stakeholders.

• Review scientific and regulatory documents, perform gap analyses, and offer recommendations.

• Draft and/or evaluate essential regulatory documents, including Investigational Medicinal Product Dossiers (IMPDs) and clinical trial justifications.

• Organize and assist with European centralized submissions and global country submissions.

• Ensure that project deliverables are achieved on schedule, within scope, and in compliance with regulatory standards.

• Maintain precise records in internal systems, databases, and tracking tools in alignment with SOPs.

• Support business development efforts by offering regulatory expertise.

• Conduct regulatory training and presentations as necessary.

• Mentor junior team members and participate in departmental knowledge-sharing initiatives.

⛳️ Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related discipline.

• Generally, 3–5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, CRO, or clinical research sectors.

• Experience in assisting with clinical trial submissions and regulatory documentation.

• Strong skills in scientific writing, document review, project management, and stakeholder engagement.

• Advanced understanding of clinical trial regulations and regulatory submission processes.

• Comprehensive knowledge of regulatory affairs and clinical trial submission criteria.

• Robust analytical and problem-solving capabilities.

• Excellent communication and collaboration skills.

• Ability to operate independently and handle multiple priorities in a fast-paced setting.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible work hours and remote work options.

• Supportive and collaborative work environment.