03 set - Spoleto
EUSA Pharma
ph3Job Purpose /h3 pWe are looking for a Regulatory Affairs Specialist to join the International Corporate Regulatory Affairs team, responsible for managing regulatory activities for SPC medicinal products for human use. /p h3Responsibilities /h3 pResponsibilities include obtaining and maintaining marketing authorizations 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 ul liNew Marketing Authorisation ApplicationsLine-extension, /li liRenewal of Marketing Authorizations /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 liRequest for Notified Body Opinions /li 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 pMore than 5 years of experience in Regulatory Affairs within multinational pharmaceutical frims (ideally at "parent companies") or international regulatory consulting companies Experience with the EU Centralised xysqume and Decentralised Procedures Background in OTC product development and lifecycle management High level of autonomy in managing assigned activities /p h3Technical Competencies /h3 pIn-depth knowledge of pharmaceutical legislation for medicinal products for human use and medical devices Experience in the use of electronic systems for the management of data and regulatory documents (RIMS, DMS, eCTD platform) /p 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 /liliStrong work ethic /li /ul h3Required Languages /h3 pFluent in English /p /p #J-18808-Ljbffr
04 set - Padova
immobiliare.scorpion
04 set - Ceglie Messapica
laboanna soc. coop.
04 set - Afragola
TITANIUM
04 set - Vicenza
Cooperativa Sociale Società Cooperativa Sociale