REGULATORY AFFAIRS ASSOCIATE (M/F)
AUSTRIA / GERMANY / SWITZERLAND

Our client, Norgine, is a leading European specialist pharmaceutical company with over 110 years of expertise and a presence in all major European markets. 


Norgine is currently looking for a Regulatory Affairs Associate, who is responsible for assisting the Regulatory Affairs team to which she/he is assigned. This role is based in Vienna and you are acting in a capacity on behalf of Norgine Pharma GmbH/Vienna, Norgine GmbH/Wettenberg, Marpha GmbH/Wettenberg and Norgine AG/Muttenz. 


Your tasks

 

  • To support the Regulatory Affairs team with the preparation and submission of high quality documentation or 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 or 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


 

Your qualifications

 

  • Degree in a relevant life science subject or a consistently good performance as Regulatory Affairs Administrator or equivalent
  • Ideally some relevant experience in the pharmaceutical industry
  • An awareness of the drug development process
  • Developing regulatory knowledge
  • Developing product knowledge
  • Demonstrates an ability to analyse data
  • Focuses 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 German and English

 

 

Remuneration: A minimum of € 30.000 gross annual salary. Any potential overpayment depends on professional experience and qualifications 

 

If you are interested in this challenging position, please forward your CV, motivation letter including salary expectations and a recent photograph to  jobs2@eblinger.at