Senior Regulatory Affairs Associate – CTA, MAA

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

📋 Description

• Prepare, submit, and oversee Clinical Trial Applications (CTAs) serving as the Local Regulatory Contact (LRC) and/or Regulatory Lead (RL).

• Assist with CTIS submissions, amendments, notifications, and interactions with regulatory authorities.

• Manage post-authorization activities, which include variations, renewals, transfers, and other lifecycle maintenance processes.

• Review and update product information documents (SmPC, PIL, labeling texts) and artwork materials to ensure compliance with local and EU regulations.

• Collaborate with internal project teams, clients, and regulatory authorities to guarantee timely and compliant submissions.

• Track regulatory commitments, maintain documentation, and support the implementation of regulatory strategies.

• Operate under the general guidance of a Project Lead and/or Technical Subject Matter Expert (SME) to ensure that client deliverables are completed on time and meet quality standards.

• May take on a client-facing role with support and guidance from management.

⛳️ Requirements

• A university degree in a life science discipline.

• Previous experience in regulatory affairs focusing on CTA and MAA activities within the EU.

• Solid understanding of Czech/EU clinical trial and medicinal product legislation.

• Experience in lifecycle management activities (variations, transfers, renewals) and maintaining product information.

• Strong organizational abilities, meticulous attention to detail, and capacity to handle multiple projects simultaneously.

• Excellent communication skills and the ability to work independently in an international setting.

• Proficiency in English, both written and spoken.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Flexible working hours and a supportive work environment.

• Comprehensive health and wellness programs.