REGULATORY AFFAIRS ASSOCIATE XIROMED

We hire: Regulatory Affairs Associate…with an untamed attitude to solutionsMedical Valley/Xiromed is a fast-growing Generic Company focused on tender markets in North Europe. We aim to deliver savings in older pharmaceutical therapies, allowing states and insurance systems to allocate more resources to newer, more efficient, and costlier therapies leading to a sustainable healthcare system in North Europe. Medical Valley/Xiromed with HQ in Höllviken is operating in 10 countries in north EU selling approx. 120 different products in various therapeutic areas. Although we are an independent company our mother company is a larger group of developing and manufacturing pharmaceutical companies, named INSUD Pharma based in Spain. INSUD Pharma has more than 6500 employees and a turnover exceeding 1.5 bn EUR.ProfileWe are looking for a dynamic, capable, curious, and innovative person to join our Regulatory Affairs (RA) team. You will be part of forming the RA function as we continue our journey of growth in a fast-paced entrepreneurial environment. You will be trained and challenged to take the full responsibility to manage the full RA-work for parts of our portfolio.You are goal- and result-oriented, have a structured approach, are service-minded, and enjoy working in teams. You thrive under occasional pressure and can take lead to manage your tasks effectively from start to end. You can find pragmatic solutions to quickly solve problems with a lean approach. You will prioritize according to the commercial goals of the company while ensuring full regulatory compliance.You will be in Azuqueca de Henares, as part of a team, and report directly to the regulatory affair manager in Spain.General Responsibility Manages new regulatory submissions and assisting with the lifecycle management of the existing portfolio, ensuring alignment of regulatory activities and commercial goals.Full ownership from submission until approval.Organizing regulatory information, logs/tracking and issuing compliance program for any Marketing Authorization.Specific Responsibilities of new MAAs and dossiers’ management until its closure, managing the deficiency letters coming from Authorities.all related activities for national phases submission, such as translations of product information with national consultants and mock-ups creation with design departments, and close follow-up with authorities until MA is granted.that any condition to the marketing authorization is completed.AWs development according to internal procedures and digital tools to be added to the company’s master file in close interaction with launch timelines.and prepare any involved documentation required for variations - administrative, quality or safety related ones- in liaison with internal policies and/or proper partners.Competent Authorities and/or vendors on general lifecycle management activities until its approval.of AWs portfolio after regulatory activities’ approval guarantying that implementation date is respected and shared with AWs and Supply Chain departments.renewals in timely manner and ensuring timelines are shared with relevant parties and in every market.of essential documents, such as Product Information, approved mock-ups, letters of approvals and updated AWs in regulatory server.sure that the regulatory database is up to date for every product and marketing authorization to fulfillxEVMPD obligations.sunset clause to be avoided.interested parties on the regulatory status for current portfolio based on internal procedures.up to date on latest regulatory requirements in Europe and share potential impact to the involved parties.eCTD documents.Requirements and personal skillsEducation: Degree in Health Sciences (preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary or similar).Languages: Fluent English is a must. Other languages will be an asset, especially Nordic/German languages.Experience (years/area): 2-5 years of experience in the mentioned functions above within a regulatory department of a pharmaceutical industry.Specific Knowledge: Knowledge of eCTD structure for preparation of module 1 and CMC expertise. Experience in portfolio management in connection with generics or branded generics (copies) for decentralized procedures. Awareness or regulatory affairs environment, EU-wide legal framework, and European authorities’ websites.Personal skills: Effective communication both verbally and in writing.Become part of an expanding pharmaceutical company in which we offer:Life and accident insurance.Free online training platform.Free online library.Social, physical and emotional well-being platformCOMMITMENT TO EQUAL OPPORTUNITIESInsud Pharma is aware that business management has to be in line with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current legislation on the subject - Organic Law 3/2007, and we do not discriminate against any person on grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.