Specialist Regulatory Affairs Milano

Specialist Regulatory Affairs
Milano
Lombardia, Milano

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives.

At Alexion, people living with rare and devastating diseases are our Guiding Star.

We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives.

We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

**Regulatory Affairs Specialist - Italy

**Location**:

Alexion Italy - Milan

**Position Summary

The RA Specialist works under the responsibility of the Regulatory Affairs Manager Italy.

He/she will provide support to the local regulatory activities managed by the Regulatory Affairs Manager Italy in accordance with Alexion policies and local regulatory requirements.

The position is based in Milan.

**Principal Activities

- Review and submit to AIFA promotional and non-promotional materials in accordance with the Pharmaceutical Lawn.

219/2006

- Submission to AIFA for approval of Congresses' sponsorship

- Periodic communications to Regions and AIFA on Numbers of HCP visited by RAM

- Management and local implementation of Risk Management Plan (education materials, certificate of vaccinations)

- Managing translations in Italian of text documents (SmPC, package leaflet.

labelling)

- Manage packaging changes for Alexion Pharma Italy marketed products

- Monitor regulatory/pharmaceutical regulations (Regulatory intelligence)

- Partner with local pharmacovigilance department in implementing the risk minimization measures

- Drafting and updating SOPs under regulatory responsibility

**Education

- 2-3 year experience in pharmaceuticals industry in regulatory affairs

- Pharmacist or equivalent education in a life science (biology, chemistry, etc.

)

- Master in Regulatory Affairs will be a plus

**Preferred Qualifications

- Ability to work independently

- Ability to build team relationship and collaborate in a global team environment at all level of the organization.

- Good interpersonal communication and organizational skills.

- Fluent in English oral and written communication.

- Ability to work in a flexible environment to meet all regulatory requirements and business requirements

- Good Computer skills (Excel, Word, Power Point)

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease.

If you're interested in career opportunities with AstraZeneca, click here.