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 looking for Regulatory Affairs Professionals on various levels (Consultant and Senior Associate) for client dedicated projects within Parexel FSP Group who are CMC Technical Regulatory Writers. Technical Regulatory Writer is involved in the client’s regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions. This role can be office or home based in various locations in UK and EU. Job Responsibilities: Write CMC parts and new files Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion Ensure the coordination with the departments involved in the writing/review process Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities Monitor that supportive data provided by other departments are compliant Report significant issues Manage the projects within all tracking tools Assess the change controls that relate to pure facilities and equipment matters or work with other teams for change controls impacting both CMC and facilities. Skills and Experience required for the role: Experience in writing CMC (technical) parts of regulatory documents (registration files or variations). Knowledge of regulatory procedures / systems / guidances Experience working with biologics / vaccines / small molecule Knowledge of Qualification / Validation principles. Manages own time to meet agreed short-term targets Analytical skills, creative and critical mind; ensures the coherence between contributions / quality of final results Good level of spoken and written English (other European language would be a plus) Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.