Role: Regulatory Associate – CTA Contract: 12-month rolling Office- Maidenhead (hybrid) – 3 days on site SRG are partnered with a global biopharmaceutical company with focus and capabilities to address some of the world’s greatest health challenges. The Regulatory Associate is responsible for providing global regulatory expertise for Clinical Trials. They are the primary interface between global functions and affiliates to deliver clinical development regulatory strategies, operations and outcomes. as well as operational support for Regulatory submission preparation and processing of amendments. SME on all aspects of EU CTR submissions including platform and complex trials, guiding cross functional teams through the process and providing training and education on the processes. Lead CTA specific scientific advice procedures, including advising study teams and management of the different options and leading strategies on when to utilize Monitor key project milestones (actual vs. Support inspection readiness activities when applicable Review and maintain awareness of regulatory intelligence relating to clinical trials and advise stakeholders accordingly. Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities. Excel spreadsheets, Power Point presentations. Undertake all necessary training in order to achieve compliance with internal/external processes Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company Bachelor's degree in medicine, pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required. At least 5-6 years CTA experience, preferably in global clinical trial submissions to regulatory agencies. Experience working effectively across cultures and in a complex matrix environment Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and global databases. fluency in English. Ability to establish and maintain excellent working relationships with primary interfaces located at remote geographical sites Strong Project Management skills, able to manage multiple activities in line with business priorities and study time goals Understands business needs and impact of regulatory issues on these.
Regulatory Consultant (Remote) in Maidenhead employer: SRG
As a Senior Clinical Trial Manager at our company, you will thrive in a dynamic and collaborative work environment that prioritises innovation and employee development. We offer competitive benefits, a strong focus on professional growth, and the opportunity to work alongside industry leaders in a location renowned for its commitment to advancing clinical research. Join us to make a meaningful impact in the field of clinical trials while enjoying a supportive culture that values your contributions.
