Senior Regulatory Affairs Specialist – CTA, Clinical Research

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

📋 Description

• Spearhead discussions and coordinate global regulatory strategies for Phase 1 to 4 clinical trials, studies, and projects.

• Offer regulatory guidance and execute projects in the provision of regulatory affairs services while serving as a liaison with both internal and external clients.

• Represent the regulatory department across other departments, supporting business development, participating in initiatives, and contributing to quality enhancement.

• Organize, lead, and document outcomes from meetings with clients and regulatory agencies.

⛳️ Requirements

• Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic/vocational qualification.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary to perform the role.

• Familiarity with the global clinical trials landscape.

• Proficient command of the English language (both written and oral) as well as the local language where applicable.

• Exceptional attention to detail and quality, alongside strong editorial and proofreading skills.

• Outstanding interpersonal skills to collaborate effectively in a team setting and liaise with other departments.

• Advanced computer proficiency, including Microsoft Word, Excel, and PowerPoint; able to quickly learn new technologies.

• Strong organizational, time management, and planning abilities to create and adhere to timelines, engage in long-term planning, adapt to shifting priorities, and manage multiple projects.

• Ability to work autonomously and apply independent judgment to evaluate sponsor regulatory needs while collaborating with project team members to deliver compliant outputs.

• In-depth understanding of global, regional, and national country requirements and regulatory affairs processes for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines.

• Excellent analytical, investigative, and problem-solving capabilities.

🏝️ Benefits

• Competitive salary.

• Extensive benefits package focused on health and well-being.

• Flexible working culture that promotes work-life balance.