Author: Monster Job
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
responsabilità
The 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
Finally, 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.
esperienza
1 anno
competenze
The ideal candidate has:
- 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.
We offer a 12 month fixed term contract with the possibility of both personal and professional growth.
Level and salary will be adjusted according to the candidate’s experience.
Work area: Cologno Monzese (MI) and remote.
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livello di studio
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