**In this key role in our business, you will be responsible for planning and managing all regulatory and quality-related activities at Norgine Italia.
This is a key member of the Leadership Team, supporting the regulatory and quality related interests of the business unit.
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**Sound interesting?
Then read on**
You will act on behalf of Norgine Italia as Regulatory Affairs Manager and as Affiliate Quality Management responsible (QMR.)
You will also be RP in Norgine Italia as well as Certification Team member in Norgine Italia, supporting the Business Integrity
You will also manage audits ensuring compliance with applicable Code of Practice
Ultimately, at Norgine, we look for the following skills and experience in our Regulatory Affairs Managers;
- Extensive regulatory experience, part of which should have been gained operating at a senior level
- Extensive regulatory knowledge essential, including medical devices regulations
- A full strategic understanding of the drug development and life cycle management principles and processes
- Qualification and experience on Applicable Codes and GDP
- Training in Applicable Codes and keep up to date with applicable case law
- Line management experience
- Demonstrates an ability to analyse and summarise data to a high level
- Focuses on customer needs, follows up on commitments and requests
- Proven strategic ability
- Excellent interpersonal skills
- Excellent verbal/written communication skills
- Excellent leadership skills
- Works cooperatively within a team and leads team as appropriate
- Exercises considerable autonomy in decision making and objective setting
- Ability to communicate clearly in English
**Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand.
We also have a strong global network of partnerships in non-Norgine markets.
We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure.
This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.