Westerman is a leading firm of high-value intelligent solutions in the area of executive search whose work philosophy is based on the combination of the boutique model of international headhunting with a strong digital approach based on e-searching.We collaborate with a company in the pharmaceutical sector with an international presence in the search for an EMEA Regulatory Affairs Specialist.The main functions to be developed are: Ensure compliance with all the relevant regulatory, pharmacovigilance and quality requirements in Europe Implement the Regulatory submission strategy in Europe, with a focus on the B2C activities (direct sales in the market) Support the new product submissions in Europe, primarily via DCP, and co-ordinate the national phase Support the maintenance of granted marketing authorizations and co-ordinate variations Liaise with the Global RA, QA and Pharmacovigilance function Support the BD function and interact and resolve any Technical Issues with our Customers Support the activities of the Qualified Person for Pharmacovigilance (QPPV) and the maintenance of the European pharmacovigilance system, including the population and maintenance of the EMA Article 57 database (xEVMPD): Support QA-related activities that are required for the running of the business in Europe such as the maintenance of WDL/MIA licences in Europe, and the establishment of Quality agreements Support the method transfer and batch release process in Europe, and ensure co-ordination with the manufacturing sites Liaise with European Health Authorities Represent the company and the department during interactions with clients, providers and consultants Propose and implement new standard operation procedures Keep up-to-date with the current EU legislative guidelines Requisitos At least 5 years´ work experience in a Regulatory Affairs department with significant involvement in EU procedures and, preferably, with exposure to Pharmacovigilance and Quality Assurance & compliance Science Degree and preferably a post-graduate Master in Industrial pharmacy Excellent written and verbal communication skills.Fluent in English and Spanish, a 3 rd European language is a plus Strong communication skills and IT fluency; proficient in Word, Excel and Outlook Ability to manage complex projects and multi-task Excellent organizational skills Ability to flourish with minimal guidance, be proactive, and handle uncertainty Comfortable using a computer for various tasks Being Professional & punctual, well-organised Team Player.Ventajas You will join a great project in expansion of a pharmaceutical company with a strong international presence.You will develop a profile with European scope and in collaboration with the different international departments of the company.Competitive salary Hybrid and flexible working mode
