Regulatory Affairs Associate Austria / Germany / Switzerland (M/F)

Vienna, Austria · Regulatory Affairs

Description

MAIN PURPOSE:

The Regulatory Affairs Associate is responsible for assisting the Regulatory Affairs for Austria, Germany and Switzerland.

MAIN TASKS

• To support the Regulatory Affairs team with the preparation and submission of high quality documentation for regulatory submissions, following current best practice standards

• To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to communicate with regulatory authorities in order to expedite approval of submissions, as directed by line manager

• To assist in the preparation and maintenance of product labelling for appropriate markets in cooperation with local regulatory, medical and commercial contacts, including translation of text changes

• To assure implementation of artwork according to legal timelines by coordination with relevant functions/partners

• To maintain the paper and electronic filing systems for assigned submissions, following Records Retention procedures

• To assist in the resolution of straightforward regulatory issues

• To work under supervision on uncomplicated projects, and to progress to working more independently

• To provide regulatory service to the Regulatory Affairs team as required by their team, including, but not limited to: monitoring of license databases, IFA-notifications, collation and provision of regulatory intelligence information, monitoring of sunset clause deadlines

You will be acting in this capacity on behalf of Norgine Pharma GmbH/ Vienna, Norgine GmbH/ Wettenberg, Marpha GmbH/ Wettenberg, and Norgine AG/Luzern.

Requirements

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

Norgine specialises in gastroenterology, hepatology, cancer and supportive care.

Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.

For more information, please visit www.norgine.com

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

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

Please note that we do try to provide specific feedback to all applications, however sometimes due to the volume of applications received we can respond only to those candidates who best match the position requirements.

Apply for this job