Regulatory Affairs Specialist - Milano, Italia - AstraZeneca

AstraZeneca

Azienda verificata

Milano, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Regulatory Affairs Specialist (maternity leave)
At AstraZeneca we believe in the potential of our people and you'll develop beyond what you thought possible.

We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

As
Regulatory Affairs Specialist (maternity leave) in Italy, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives.

Our scientific research is absolutely forefront in Oncology, Respiratory, CardioRenal Metabolic diseases and one of the most promising in the whole industry.

You will be among inspiring industry leaders who will keep you engaged and empower you to be the best.

We seek out opportunities to do dynamic and significant work which means we won't just follow the same course of action time and again if we can see potential in a different way of building life changing medicines.

As
Regulatory Affairs Specialist you will collaborate to achieve and maintain regulatory authorisations for the new and existing products pertinent to AstraZeneca Therapeutic Areas of focus, in compliance with local legislation and MC Code/SOPs, as well as guarantee the maintenance and compliance to GRP and local SOPs.

If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us.

MAIN DUTIES AND RESPONSIBILITIES

The role broadly includes the following key components:

Supporting all activities related to the registration and maintenance of products in compliance with all local and global codes, standards and procedures
Assisting with regulatory file compilation and submissions, regulatory approval and maintenance procedures including maintenance of regulatory databases
Following up the variations approval process implementing the regulatory activities established by the law and by AstraZeneca
Maintaining regulatory/technical archive of product and tracking of submission/achievements being able to satisfy the requirements of any audit or inspection
Reviewing of promotional materials, from a regulatory point of view, in order to guarantee the compliance with local legislation and MC Code/SOPs
Manage all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures and Italian legislation

ESSENTIAL REQUIREMENTS

Scientific Degree
Preferable 1 or 2 years of professional experience in Regulatory Affairs field within a pharmaceutical company or health care authority
Good knowledge of National and EU pharmaceutical legislation
Knowledge of the local and HQ SOP and Codes
Knowledge of informatics system and programs
Excellent communication and teamwork skills
Precision and accuracy
Flexibility
Fluent in Italian and English

DESIDERABLE REQUIREMENTS