.Senior Associate/Specialist, Regulatory Intelligence and Analytics Full-timeDepartment: Regulatory Intelligence and AnalyticsWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.PrimeVigilance provides first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in its field. We cover all therapy areas, including medical devices.We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being, and mental health, acknowledging that a healthy work-life balance is critical for employee satisfaction and nurtures an environment for high-quality client service.Come and join us in this exciting journey to make a positive impact in patients' lives.The Senior Associate, Regulatory Intelligence and Analytics is responsible for completing regulatory deliverables based on an established regulatory plan. They also serve as a liaison between regulatory and other functional areas, including external partners, clients, authorities, and/or consultants in planning, organizing, and preparing regulatory deliverables following project, corporate, and industry regulatory strategies.Role and Responsibilities Provide intelligence on requirements and contribute to the development of the strategy and setup activities including Regulatory Management Plan, joint operating procedures, POAs, and core documents. Support identification of issues.Perform regular screening of regulatory legislative requirements updates and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes.Provide internal teams with guidance on national requirements.Ensure compliance with company procedures, processes, training records, systems, and other tools.Promptly identify and escalate risk/potential risk to the project team which may jeopardize deliverables.Maintain awareness of allocated tasks and hours and promptly identify and escalate any OoS.Provide administrative support to BD activities.Foster professional working relationships with internal and external contacts at local and international levels to ensure smooth and efficient service delivery.Participate in preparation for audits/inspections and provide department representation for assigned projects as required.Provide feedback on the performance of vendors to aid their assessment.Minimum Requirements Degree in Chemistry or Life Sciences, Nursing, or equivalent experience.Previous regulatory experience within the pharmaceutical/CRO industry.Good planning and organizational skills