REGULATORY AFFAIRS SPECIALIST - TEMPORAL

Insud Pharma is a recognized and respected company in the pharmaceutical and healthcare sector with more than 40 years of history.Chemo, an industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 drugs with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).Global Responsability:Assisting with the lifecycle management of the existing portfolio making sure that the variations will be submitted in time to ensure regulatory compliance.Specific Responsibilities:Prepare the necessary documentation needed for the submission of any variations.Support and provide the necessary documentation to local affiliates and clients for the submission of the variations.Support and provide the necessary documentation to local affiliates and clients to answer the LoDs related with the submitted variations. With the aim to receive the MA as soon as possible.Archiving of essential documents and ensure that the related documentation and email are archived and updated in line with company procedure.Make sure that the essential information from the dossier post approval are shared with implicated departments according to relevant procedures.Make sure that the regulatory database is up to date for his/her projects in the region.Stay up to date on latest regulatory requirements related to post-marketing activites.What we offerContract: Temporary initially (6-8 months).Innovative Projects: Be part of cutting-edge projects that are making a difference in the industry.Collaborative Culture: Work alongside a talented and diverse team of professionals who value collaboration and knowledge-sharing.Supportive and Inclusive Atmosphere: We create a work environment where everyone feels valued, supported, and encouraged to grow both personally and professionally.Continuous Learning: We are committed to helping you grow by providing access to learning resources, training programs, and workshops.Requirements and personal skillsEducation: Degree in Health Sciences (preferably Pharmacy, but also Chemistry, Biology, Biochemistry, Veterinary or similar).Languages: Fluent Spanish and English, knowledge of other languages will be an asset.Experience (years/area): Previous experience in the regulatory department of a pharmaceutical industry would be desirable.Specific Knowledge: Knowledge in eCTD dossier. Preferably have previous connection with generic or branded generics (copies). Knowledge of International Standards in terms of drug registration. Knowledge of international markets and distribution business is desirable.Personal skills: Initiative and proactivity, ability to make decisions autonomously, decisiveness.COMMITMENT TO EQUAL OPPORTUNITIESLaboratorios Leon Farma / Farmalan is committed to equal opportunities.We do not discriminate against any person on the 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.