Senior Specialist/Manager, Regulatory… at ERGOMED · Zagreb

companyDescription PrimeVigilance (part of Ergomed Group), is 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 all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. jobDescription Main responsibilities: Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates. Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes. Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures. Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures. Ensure compliance with company procedures, processes, training records, systems and any other tools Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS. Provide support to proposal development and input to budgets, provide department representation to BD meetings as required. Provide training, coaching and mentoring to junior members of staff. Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery. Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required. Provide feedback on performance of vendors to aid their assessment. Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance. Would be required to line manage for the Manager level position qualifications Degree in Chemistry or Life Sciences, Nursing or equivalent experience. Strong previous experience within pharmaceutical or CRO industry or Regulatory body Previous Project Management experience is desirable Knowledge of Pharmacovigilance/Regulatory field Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency. Fluent Proficiency in English, both written and verbal. Additional languages are desirable. Strong organization skills and detailed orientated approach to work additionalInformation Why PrimeVigilance We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application.