We are looking for a Regulatory ProfessionalWorld leader in allergyALK's aspiration is to become the world leader in allergy by helping as many people as possible to a better life by providing options of prevention, diagnosis, and treatment of allergy.Experience and qualifications required in the job=3 years as Regulatory Affairs Professional in a pharmaceutical company, preferably multinational.Experience in international projects will be an asset.Bachelor of Science / Master of Science in the Health Science field (e.g. Pharmacy, Biology, etc.).Master's Degree in the Pharmaceutical Industry is strongly recommended.Specific regulatory affairs courses strongly recommended.ResponsibilitiesHandling regulatory CMC documentation of the products manufactured at site Madrid, for world-wide submissions (MAA, Variations, Renewals).Maintenance activities (CMC variations) for the products manufactured at site Madrid and registered world-wide.Local regulatory activities for the products registered in Spain.Handling product information (SmPCs, leaflets, labels).Regulatory surveillance & regulatory support to other functional areas.Member of cross-functional / cross-site projects.Important tasks to be handled in the job:Coordination, preparation & submission of CMC documentation (CTD Modules 2.3 & 3) for Marketing Authorisation Applications / Variations / Renewals of products manufactured at site Madrid, in compliance with local or regional requirements, including input to the regulatory strategies & responses to questions from regulatory authorities during assessment.Coordination, preparation & submission of CMC documentation for post-approval regulatory commitments.Handling the national phase of variations/MAA submitted by European procedures (MRP/DCP) for products manufactured at other ALK sites - including fee payment, translation to local language of product information (SmPC, PL, Labelling), change requests for printed packaging materials – and follow-up with AEMPS until approval.Preparation & submission of documentation on products manufactured at site Madrid, to obtain special licences/import licenses in other countries.Reviewing change control requests, including assessment of regulatory impact, defining variation classification/documentation needed and submitting the corresp0nding variation applications.Writing/adapting to local requirements SmPCs, PL, labels & abridged SmPCs for promotional materials.Applying for Certificates of Pharmaceutical Products (CPP) / Free Sale Certificates / other & handling or coordinating the subsequent legalization process.Handling local activities for the products registered in Spain, e.g. product launch notifications & applications for yearly maintenance of the products via AEMPS portal.Providing regulatory input to the Annual Product Quality Review (APQR).Electronic archiving of all documentation concerning MAA/variations submitted & authorised for the products under his/her responsibility in the VEEVA RIM system, ensuring they are kept up to date.Keeping abreast of regulatory procedures & changes to national/international legislation and providing regulatory support to other functional areas / sites.Participating in strategic international projects.CompetencesKnowledge of the European Regulatory Environment (procedures, legislation, guidelines, CTD, etc)Fluent in English – experience in writing technical / scientific documentation in English.Personal SkillsOrganised, methodical and pays great attention to detail.Collaborative - works well as a team, but also autonomously and able to take own decisions.Problem-solving attitude.Goal-oriented.Not afraid of challenges.Good communication skills (especially written).Quick to learn.Takes responsibility for own work.Adapts quickly to change.Important informationThe position is based at ALK's site in Madrid, located in the business area of Ciudad Lineal. We have a quick access to the Hermanos García Noblejas and Ascao metro stations and a wide bus connection network. The production site is located at Calle Miguel Fleta 19 while the Business Support area is next door, Santa Leonor 65, in a building called Avalon Business Park. Nevertheless, we have a remote working policy that will allow you to work from some days (you will receive ad-hoc information in the recruitment process).ALK, among other benefits, has a canteen where employees can have breakfast and lunch every day.If this sounds like a company mission, job and a department you would like to be part of, we hope to receive your CV and application, but please do not send your CV via e-mail due to GDPR rules.#J-18808-Ljbffr
