Regulatory Affairs Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fw8yu

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.
Responsibilities 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 liPreparation, review and submission of regulatory documentation to Health Authorities.
/li liManagement of regulatory data and documentation within relevant electronic systems, in support of new marketing authorization applications.
/li liLine 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 regulatory authorities.




/li liMonitor legislation in force and assure 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 ul liMore than 5 years of experience in Regulatory Affairs within multinational pharmaceutical firms (ideally at parent companies) or international regulatory consulting companies.
/li liExperience with the EU Centralised and Decentralised Procedures.
/li liBackground in OTC product development and lifecycle management.
/li liHigh level of autonomy in managing assigned activities.
/li /ul h3Technical Competencies /h3 ul liIn-depth knowledge of pharmaceutical legislation for medicinal products for human use and medical devices.
/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 liStrong work ethic.
/li /ul h3Required Languages /h3 ul liFluent in English.
/li /ul 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-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7fw8yu