PFounded in 1946, Fidia is an Italian multinational pharmaceutical company, with RD, manufacturing, marketing and sales capabilities, and an extensive product portfolio, mainly based on Hyaluronic Acid, in strategic therapeutic areas such as Joint Care, Skin Care, Eye Care, HealthWellness Care, Specialty Care, Regenerative Care and Aesthetic Care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as wholly own subsidiaries. /ppbr/ppWe are recruiting a /ppbr/ppstrongRegulatory Affairs Expert /strong /ppbr/ppBeing part of the Regulatory Affairs Team, the candidate will support the team in all the activities needed for the lifecycle of the medicinal products worldwide. /ppbr/ppstrongMain Responsibilities: /strong /pulliSupporting the preparation of the regulatory package, responses to HAs requests, submission of the package, follow-up of the pre- and post-approval activities of all the regulatory practices (including MAA, VA, MA transfers, MA renewal) of the MAs of the medicinal products. /liliManagement of the changes to the product information and relevant artworks, collaboration with the Pharmacovigilance Department and Scientific Service to guarantee the correct management of the safety variations. /liliMaintenance of the internal and external databases. /liliContacts with subsidiaries/distributors worldwide to get information on requirements for planning regulatory activities. /liliContacts with other Fidia HQ departments and affiliates functions to support the team in all regulatory activities. /li /ulpbr/ppstrongRequirements: /strong /pulliDegree in Life Science disciplines, preferably in Pharmacy or CTF, Biological Sciences, Chemistry. A specialization in Regulatory Affairs is a plus. /liliAt least 1 year of experience in the regulatory field with a focus on medicinal products, preferably in companies with a manufacturing site for medicinal products. /liliKnowledge of pharmaceutical regulations, GMP and relevant guidelines. /liliExperience in managing national or European registrations (DCP, MRP). /liliExcellent proficiency in MS Office and preferable knowledge of eCTD Manager. /liliExcellent knowledge of written and spoken English. /liliStrong teamwork, active listening, accuracy, flexibility, and ability to learn. /li /ulpbr/ppstrongOur offer: /strong /pulliOpen ended contract. /liliSalary between € 30.500 and 38.000. /liliCollective Bonus and company Welfare. /li /ulpbr/ppstrongFidia benefits: /strong /ppIn Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign. /ppbr/ppemFidia Farmaceutici promotes parity and inclusion in all its actions. /em /ppemAll people from the status of candidate to that of employee and throughout the duration of their employment relationship are entitled to the same opportunities and protections regardless of gender identity, sexual orientation, ethnicity, migration background, religion, nationality, age. /em /ppemAll company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People Culture Department. /em /ppbr/ppstrongWe are upgrading our recruitment platform to improve your candidate experience. /strong /ppstrongFrom May 25 to June 15, the platform will be unavailable and it will not be possible to access or submit applications. /strong /ppbr/ppstrongBy submitting your application via email, you acknowledge that you have read the privacy notice uaavailable here /a /u. /strong /p