As Regulatory Affairs Specialist 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 variation 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
- Scientific Degree
- 2-3 years of professional experience in Regulatory Affairs field within a pharmaceutical company or health care authority or regulatory consultancy
- Knowledge of centralized procedure is highly preferred
- 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
- Fluent in Italian and English
- Further qualification/Master in Regulatory field