PJoin to apply for the Regulatory Affairs Specialist role at Fidia Pharma /ppJoin to apply for the Regulatory Affairs Specialist role at Fidia Pharma /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, Eye care, Skin care, Specialty care, HealthWellness care. Headquartered in Abano Terme (PD), Fidia extends its global reach through local partners and distributors in 120+ countries worldwide, as well as with wholly owned subsidiaries. /ppWe are recruiting a /ppbRegulatory Affairs Specialist /b /ppBeing part of the Regulatory Affairs Team, the candidate will take care of the lifecycle of the medicinal products. He / she will be in charge of preparing regulatory documents for medicinal products, maintaining the product dossiers to guarantee that the most updated information is submitted and approved by the concerned Competent Authorities, with the supervision of the Manager. /ppbMain Responsibilities : /b /pulliManagement of 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. /liliMonitoring, individuation, analysis and evaluation of the impact of new regulatory requirements. /liliRevision and submission to the Italian HAs of the medicinal product promotional materials for HCPs and public. /liliMaintenance of the compliance of the regulatory documentation with respect to the manufacturing of API and finish products performed in Fidia plants and CMOs. /liliContacts with the CAs and subsidiaries / distributors as well as other Fidia HQ functions to coordinate all regulatory practices. /li /ulpbRequirements : /b /pulliBachelor Degree in Life Science disciplines, preferably in Pharmacy / CTF / Biological Sciences / Chemistry. A specialisation in Regulatory Affairs is a plus. /liliAt least 5 years' experience in the regulatory field with a focus on medicinal products, preferably in companies with a manufacturing site for medicinal products. /liliKnowledge of medicines legislation, GMP and reference guidelines. /liliExperience of European registrations (national, DCP, MRP). /liliExperience in using the various applications of the AIFA portal. /liliExcellent experience of the MS Office package and good knowledge of eCTD Manager. /liliFluent in both spoken and written English. /liliSkills of team working, critical thinking and planning, meeting deadlines efficiently. /li /ulpbOur offer : /b /pulliOpen ended contract. /liliB” grading of Chemical Pharmaceutical National Collective Agreement. /liliSalary between € 38.600 and 45.500. /liliCollective Bonus and company Welfare. /li /ulpIn 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. /ppFidia Farmaceutici promotes parity and inclusion in all its actions. /ppAll 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. /ppAll 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. /ppbSeniority level /b /pulliSeniority levelMid-Senior level /li /ulpbEmployment type /b /pulliEmployment typeFull-time /li /ulpbJob function /b /pulliJob functionOther /liliIndustriesPharmaceutical Manufacturing /li /ulpReferrals increase your chances of interviewing at Fidia Pharma by 2x /ppSign in to set job alerts for “Regulatory Affairs Specialist” roles.Regulatory Affairs Specialist - Medical DevicesQuality Control Specialist - Transformers (m / f / d) /ppbPiombino Dese, Veneto, Italy 2 months ago /b /ppFund Administrator Regulatory Reporting - SGR Private EquityCustomer Quality Specialist - Alonte (VI) /ppWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. /ppJ-18808-Ljbffr /p #J-18808-Ljbffr