Regulatory Affairs Expert

Settore:
Assistenza SanitariaOrario di lavoro:
Full TimeContratto:
SomministrazioneNumero posti:
1Luogo di lavoro:
MilanoFor a multinational company in the chemical-pharmaceutical field, we are looking for a Regulatory Affairs Expert who will join the Regulatory affairs team and will be Responsible for all national regulatory activities related to the products portfolio enabling optimal labeling implementation & complianceThe jobholder will be in charge of:
Reviewing and submitting to local HAs for all submission types;Drafting final review of translations of product information & printed packaging materials;Enabling response to Health Authority questions;Reporting approvals to appropriate internal and external parties;Enabling the implementation & publication of national product information where required;Monitoring the implementation of national procedures.They will also:
Make sure relevant local parties are informed & aligned;Represent regulatory in Cross Teams and is responsible to provide support to local business questions on brands managed;Support other local departments based on their needs for specific product questions (PhVig, Busuness Quality, Hemar, Medical, Marketing & Sales, Finance, );Review promotional material, risk minimisation materials, tendersFollow and reports development of local regulatory regulations andguidelinesFinally, the resource will Ensure compliance with all local and regional regulatory requirements and provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints.
Requisiti: