Regulatory Affairs Trainee

hace 16 horas

Madrid, España Norgine A tiempo completo

**About Norgine**

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.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

**MAIN PURPOSE**:
The Regulatory Affairs Trainee is responsible for providing administrative support to the Regulatory Affairs to which is assigned.

**KEY RESPONSIBILITIES & ACCOUNTABILITIES**:

- To support the Regulatory Affairs team on a day-to-day basis in all administrative areas
- To provide regulatory administrative service to the Regulatory team as required

**MAIN TASKS**
- Ensuring the accuracy and optimal presentation of submission documents and any other Quality and Regulatory documentation which is in charge of.
- Providing input into submission planning, and ensuring work is carried out to agreed timelines.
- Maintaining and managing the Regulatory databases as appropriate
- To assist in regulatory & quality tasks as requested by their team
- To support the local quality tasks. Please find a non exhaustive list of them:

- Stock management.
- Packaging and Promotional material review and submission.
- Product inspection and release.
- Management of quality complaints.
- Traceability management.
- Customer qualification checks (BONA FIDES)

**RELATIONSHIPS**:
Norgine Spain Business Unit, Regulatory Colleagues, Quality Colleagues, Manufacturing and Supply, Local Pharma-companies colleagues

**Requirements**:

- Ideally having a post grade in pharmaceutical industry
- Good administrative skills
- An organised and careful approach to work
- Demonstrates a good ability to analyse data
- Focused on customer needs, follows up on commitments and requests
- Good interpersonal skills
- Good verbal and written communication skills
- Works cooperatively within a team
- Ability to communicate clearly in English
- Excellent understanding of Microsoft Office (Word, Excel, PowerPoint)

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