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 EuropeImplement 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 phaseSupport the maintenance of granted marketing authorizations and co-ordinate variationsLiaise with the Global RA, QA and Pharmacovigilance functionSupport the BD function and interact and resolve any Technical Issues with our CustomersSupport 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 agreementsSupport the method transfer and batch release process in Europe, and ensure co-ordination with the manufacturing sitesLiaise with European Health AuthoritiesRepresent the company and the department during interactions with clients, providers and consultantsPropose and implement new standard operation proceduresKeep up-to-date with the current EU legislative guidelinesRrequirementsAt 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 & complianceScience Degree and preferably a post-graduate Master in Industrial pharmacyExcellent written and verbal communication skills. Fluent in English and Spanish, a 3rd European language is a plusStrong communication skills and IT fluency; proficient in Word, Excel and OutlookAbility to manage complex projects and multi-taskExcellent organizational skillsAbility to flourish with minimal guidance, be proactive, and handle uncertaintyComfortable using a computer for various tasksBeing Professional & punctual, well-organisedTeam Player.Benefits: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 salaryHybrid and flexible working mode#J-18808-Ljbffr
