PpFounded 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. /p h3Regulatory Affairs Expert /h3 pBeing 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. /p h3Main Responsibilities /h3 ul liSupporting the preparation of the regulatory package, responses to HA 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. /li liManagement 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. /li liMaintenance of the internal and external databases. /li liContacts with subsidiaries/distributors worldwide to get information on requirements for planning regulatory activities. /li liContacts with other Fidia HQ departments and affiliates functions to support the team in all regulatory activities. /li /ul h3Requirements /h3 ul liDegree in Life Science disciplines, preferably in Pharmacy or CTF, Biological Sciences, Chemistry. A specialization in Regulatory Affairs is a plus. /li liAt 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. /li liKnowledge of pharmaceutical regulations, GMP and relevant guidelines. /li liExperience in managing national or European registrations (DCP, MRP). /li liExcellent proficiency in MS Office and preferable knowledge of eCTD Manager. /li liExcellent knowledge of written and spoken English. /li liStrong teamwork, active listening, accuracy, flexibility, and ability to learn. /li /ul h3Our offer /h3 ul liOpen ended contract. /li liSalary between € 30.500 and 38.000. /li liCollective Bonus and company Welfare. /li /ul pIn 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. /p pFidia Farmaceutici promotes parity and inclusion in all its actions. All 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. All 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. /p /p #J-18808-Ljbffr