ph3Job Purpose /h3 pWe are looking for a Regulatory Affairs Associate – Fixed‑term contract to join the International Corporate Regulatory Affairs team, responsible for managing regulatory activities for SPC medicinal products for human use. Responsibilities include obtaining and maintaining marketing authorisations in the European Union (through CP/MRP/DCP) as well as supporting regulatory activities in various non‑EU regions, including Africa, Asia Pacific, CENAM, CSI, LATAM, MENA. /p h3Key Responsibilities /h3 pThe candidate will be responsible for the preparation, review and submission of regulatory documentation to Health Authorities, as well as for the management of regulatory data and documentation within relevant electronic systems, in support of: /p ul liNew Marketing Authorisation Applications /li liLine‑extension /li liRenewal of Marketing Authorisations /li liVariations Type IA, IB, II (including grouping and worksharing procedures) or equivalent procedures in accordance with national legislation /li liMarketing Authorization transfers /li liNotification of start and end of marketing /li liRequests for Sunset Clause exemptions /li liReview and approval of printed materials (artworks and mock‑ups) /li /ul pBased on the products assigned, the Regulatory Affairs Associate will also: /p ul liDefine regulatory activity plans and related costs /li liCollaborate with cross‑functional teams to define and manage timelines for the preparation of regulatory submissions /li liContribute to the management of core dossiers, including gap analysis activities, to support registrations across multiple international markets, in collaboration with relevant departments /li liCoordinate with the group's affiliates,



licensees and consultancy companies /li liMaintain relations with the Regulatory Authorities /li liMonitor the legislation in force and assure the regulatory compliance /li liProvide regulatory assessment for new business opportunities /li /ul h3Required Education /h3 ul liScientific Degree /li liMaster in Regulatory Affairs (preferred) /li /ul h3Required Skills And Experience /h3 pAt least 6 months/1 year of experience in Regulatory Affairs within multinational pharmaceutical firms (ideally at parent companies) or international regulatory consulting companies. /p h3Technical Competencies /h3 ul liIn‑depth knowledge of pharmaceutical legislation for medicinal products for human use /li liExperience in the use of electronic systems for the management of data and regulatory documents (RIMS, DMS, eCTD platform) /li /ul h3Required Behaviours And Competencies /h3 ul liPositive and proactive mindset, with a solution‑oriented approach /li liStrong communication and collaborative skills, team‑player attitude /li liEffective time management and organisational skills /li liFlexibility and adaptability in a dynamic environment /li /ul h3Required Languages /h3 pFluent in English /p h3Salary /h3 pGross Annual Salary starting from: 36.000 € /p pPlease note: The salary indicated in this posting complies with local pay transparency regulations for Italian employment contracts. Final offers will be tailored to the successful candidate's experience, professional expertise, and interview journey, while ensuring internal equity. At Recordati, we are committed to a comprehensive, fair, and competitive remuneration system; a full overview of your total rewards package will be shared and discussed with you during the recruiting process. /p h3EEO Statement /h3 pWe are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief. /p /p #J-18808-Ljbffr

📌 Regulatory AffaiRegulatory Affairs Associate - Fix-term contractrs Associate - Temporary (Turbigo)
🏢 Recordati
📍 Turbigo