Ph3Regulatory Affairs Specialist – Fidia Pharma /h3 pJoin to apply for the bRegulatory Affairs Specialist /b role at bFidia Pharma /b. Fidia is an Italian multinational pharmaceutical company established in 1946, with research, development, manufacturing, marketing and sales capabilities, and a portfolio of products mainly based on hyaluronic acid, covering joint care, eye care, skin care, specialty care and health wellness. Headquartered in Abano Terme (PD), Fidia operates in 120+ countries worldwide through local partners and distributors. /p h3About the role /h3 pAs part of the Regulatory Affairs Team, the candidate will take care of the lifecycle of medicinal products. He/She will prepare regulatory documents, maintain product dossiers, and ensure that updated information is submitted and approved by competent authorities, under supervision of the Manager. /p h3Main Responsibilities /h3 ul liManagement 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. /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 liMonitoring, individuation, analysis and evaluation of the impact of new regulatory requirements. /li liRevision and submission to the Italian HAs of the medicinal product promotional materials for HCPs and public. /li liMaintenance of the compliance of the regulatory documentation with respect to the manufacturing of API and finish products performed in Fidia plants and CMOs. /li liContacts with the CAs and subsidiaries/distributors as well as other Fidia HQ functions to coordinate all regulatory practices. /li /ul h3Requirements /h3 ul liBachelor’s degree in Life Science disciplines, preferably in Pharmacy/CTF/Biological Sciences/Chemistry. A specialisation in Regulatory Affairs is a plus. /li liAt least 5 years’ experience in the regulatory field with a focus on medicinal products, preferably in companies with a manufacturing site for medicinal products. /li liKnowledge of medicines legislation, GMP and reference guidelines. /li liExperience of managing national procedures and using the various AIFA portal applications. /li liExperience of European registrations is a plus. /li liExcellent experience of the MS Office package and good experience of preparing eCTD sequences using eCTD Manager or similar software. /li liFluent in both spoken and written English. /li liSkills of team working, critical thinking and planning, meeting deadlines efficiently. /li /ul h3Our offer /h3 ul liOpen ended contract. /li li“B” grading of Chemical Pharmaceutical National Collective Agreement. /li liSalary between € 38.900 and 45.500. /li liCollective Bonus and company Welfare. /li /ul h3Benefits Training /h3 pUnlimited access to training and coaching programs aligned with market best practices and opportunities for professional development, internal job postings, 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 h3EEO Statement /h3 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 above; any divergences should be promptly brought to the attention of the People Culture Department. /p /p #J-18808-Ljbffr