Regulatory Affairs Associate Austria / Germany / Switzerland (M/F)
The Regulatory Affairs Associate is responsible for assisting the Regulatory Affairs team for Austria, Germany and Switzerland.
*This role can be based in Vienna, Austria or in Wettenberg, Germany*
• 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.
- Degree in a relevant Life Science subject or a consistently good performance as Regulatory Affairs Administrator, or a Law degree with some experience in the pharmaceutical industry, or similar
- Proven experience in Document management and Regulatory Affairs in at least one of the DACH countries
- An awareness of the drug development process
- A keen interest in developing regulatory knowledge
- A keen interest in developing product knowledge
- Demonstrates an ability to analyse data, strong attention to details, very organised
- Focuses on customer needs, follows up on commitments and requests
- Good interpersonal skills
- Clear verbal and written communication skills in English and in German, ideally French as well
- Capacity to work cooperatively within a team
Across the globe in 2018, Norgine is proud to have helped 23 million patients, employed almost 1,400 permanent staff and generated €395 million in net product sales to reinvest in medicines for the future, a growth of 15% since 2017.
Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. We understand the complexities of the European healthcare systems and have a direct presence in 14 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.
Follow us on twitter @norgine or visit us at www.norgine..com
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.