Regulatory Affairs Consultant (CTA) - home or office based

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are excited to announce an opportunity for a skilled and experienced Regulatory Affairs professional to join our dynamic and expanding team at Parexel . This role can be either home or office-based in Warsaw. As a Regulatory Affairs Consultant you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in C linical Trial Applications (CTA) from various European locations. You will have a chance to work on submissions for Parexel as well as dedicated for clients. In return we will offer you training and knowledge of the organization’s basic consulting models and methodologies as well as basic knowledge of what services we provide. Under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the business and the client. We will provide you with support of more senior staff to accomplish more complex tasks. You may act in a client-facing role with clear guidance and support from line management. Main responsibilities: Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development and completion of relative associated documentation as required. Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project s