Regulatory Affairs Manager – Global Clinical Trial Applications

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

📋 Description

• Oversee the creation of global regulatory submissions for Clinical Trial Applications (CTA) while ensuring high-quality standards that comply with local and regional regulations.

• Serve as a subject matter expert, offering regulatory strategy guidance and technical expertise to both internal and external clients, especially for key client projects of moderate to high complexity.

• Supervise multiple studies/projects, ensuring the alignment of regulatory strategies, quality assurance, and timely delivery.

• Act as a senior point of contact for clients, contributing to comprehensive regulatory planning and supporting proposals, bid defenses, and discussions regarding project scope.

• Ensure high-quality performance for key and managed projects.

• Oversee project budgeting and forecasting functions, maintaining accountability for financial management and scope adherence.

• Recognize and identify out-of-scope activities, collaborating with relevant teams to manage modifications to contracts.

• Work in conjunction with business development to establish pricing and secure new business by contributing to proposals, budgets, and client presentations.

• Provide matrix/project leadership and guidance to team members.

• Ensure compliance with applicable organizational and regulatory Standard Operating Procedures (SOPs) and Work Practice Documents (WPDs).

• Participate in launch meetings, review meetings, and project team discussions.

⛳️ Requirements

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

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (comparable to 9+ years).

• Demonstrated project management experience and a track record of success in a client-facing position.

• Strong grasp of global and regional regulatory requirements as well as ICH guidelines.

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

• Solid understanding of budgeting and forecasting processes.

• Exceptional communication skills in English (both written and oral), as well as proficiency in the local language where applicable.

• Keen attention to detail and quality, complemented by strong editorial and proofreading abilities.

• Outstanding interpersonal skills that facilitate effective teamwork and collaboration with other departments.

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

• Strong organizational, time management, and planning skills.

• Excellent negotiation skills.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package emphasizing health and well-being.

• Flexible working culture that values work-life balance.

• Opportunities for professional growth and development.