Regulatory Affairs Professional - CTA

Parexel • King of Prussia, PA

484d

About The Position

As a Regulatory Affairs Professional at Parexel International Corporation, you will play a crucial role in managing clinical trial submissions, particularly focusing on Clinical Trial Applications (CTA). This position requires a strong understanding of the regulatory landscape, especially in relation to the EU Clinical Trials Regulation (EU-CTR). You will be responsible for acting as the Local Regulatory Contact (LRC) for submissions in Spain, while also coordinating regulatory submissions across all participating countries as the Regulatory Lead. Your expertise in the EU-CTR process will be highly valued, and your ability to navigate the complexities of regulatory submissions will be essential for the success of clinical trials. In this role, you will participate in Regulatory Operations meetings and project team meetings, ensuring effective communication and collaboration with other departments, clients, and regulatory agencies. Your involvement may extend to local, regional, and global projects, providing you with a diverse range of experiences and challenges. You will need to demonstrate strong prioritization skills, as you will be required to manage conflicting priorities and tight deadlines while maintaining a high level of quality and attention to detail. Your ability to work effectively within a multinational team will be critical, as you will be addressing multiple issues simultaneously under pressure. The ideal candidate will possess a Bachelor of Science degree or higher and have relevant clinical research experience in regulatory affairs, particularly in the management of international clinical trials. Your creative problem-solving skills will support a client-focused approach to your work, ensuring that you can effectively address challenges as they arise. Fluency in written and spoken English is a must, as clear communication is vital in this role.