Regulatory Affairs Expert

1 settimana fa

Milano, Lombardia, Italia Confidenziale A tempo pieno
For Janssen Cilag Italy, the pharmaceutical company of the Johnson & Johnson Group, 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 & compliance responsabilitàThe 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, tenders
Follow and reports development of local regulatory regulations and guidelines
University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience. A Master in Regulatory Affairs is considered a plus;
Two years of eperience in RA;
An advanced level of english both spoken and written;
In depth knowledge of local regulations & legislation, good knowledge of EMA regulatory guidelines;
Project management skills, ability to prioritize and have a sense of urgency;
Interpersonal, communication, teamwork skills;
Ability to work under strict timelines, combined with flexible work situations when required;
Ability to adapt to new systems and procedures.

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