Principal Regulatory Affairs Specialist – Global Clinical Trial Applications

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

📋 Description

• Empowering customers to contribute to a healthier, cleaner, and safer world.

• Become a part of the global Regulatory Affairs department within the Reg Science team.

• Facilitate discussions and coordinate global regulatory strategies for assigned clinical trials.

• Deliver innovative solutions along with global regulatory expertise.

• Serve as a key liaison between internal teams and external clients.

• Organize, lead, and provide reports on meetings with clients and regulatory agencies.

⛳️ Requirements

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

• Prior experience that equips you with the knowledge, skills, and abilities necessary for the role, typically amounting to 8+ years.

• Familiarity with the global landscape of clinical trials.

• Proficient command of the English language, both written and spoken.

• Experience participating in Bid Defense meetings.

• Proven track record in leading global regulatory projects for Clinical Trial Applications.

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

• Outstanding interpersonal skills to collaborate effectively within a team setting.

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

• Strong organizational, time management, and planning abilities.

• In-depth knowledge of global, regional, and national regulatory requirements and procedures for clinical trial authorization.

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

🏝️ Benefits

• Award-winning learning and development programs.

• Focus on the health and well-being of employees.

• Flexible working culture.

• Collaborative work environment.