•  Vice President BU Pharma deutsch 
    •  Director RegAff  
|

Vice President BU Pharma

The art of distinguishing between what is important and what's not.

Identifying and setting priorities as regards what needs to be done next – that's one of the basic requirements for being successful in the Regulatory Affairs department. I quickly discovered that when I joined PARI as Associate Director. When it comes to regulatory matters, I had to find my feet pretty fast here. Luckily the HR department provided me with the necessary backup in the form of an intensive induction programme. My task was to build up the Regulatory Affairs department from scratch, responsible for dealing with the licensing of drugs and medical devices on the regulatory side. Or to put it another way: We manage the licensing process by drawing up dossiers, submissions (IMPDs) and briefing documents and handling all communications with the authorities. This involves a very wide range of duties, in particular when you take over full responsibility for the licensing of certain products.

In my case this is currently project-managing various drug developments. In this context I like looking back at the preparation and submission of the dossier for a specific product – because its successful licensing was also a first for me. And our Pre-IND meeting with the FDA, the American licensing authority, was a big thing at the time.

When it comes to day-to-day business, I of course not only enjoy managing a great team of people, but also dealing with my many pleasant colleagues at the company. When I describe the informal, relaxed atmosphere at PARI and enormous amount of freedom I'm given in my job, I shouldn't forget to mention on the other hand that all staff at PARI are extremely hardworking, motivated and quick to learn.