For  a world leading international pharmaceutical company,  we are seeking for a:

Regulatory Affairs Scientist
(32-40 uur)

for the department of Global Regulatory Affairs- Chemistry Manufacturing & Control (GRA -CMC) in Oss, the Netherlands..

The CMC department is responsible to carry out all activities that are needed to obtain new registrations and to maintain existing registrations for the projects and products of the Oss portfolio,  in particular with respect to chemical/pharmaceutical aspects of the submissions.

Because of a new project that will result in the submission of many changes on the existing registration dossiers to multiple health authorities we are looking for new staff.

This position is for 6 months but in the near future we will be looking for more people which gives more possibilities. We need a candidate to start at 1th of September at the latest.

Tasks and Responsibilities:

      -                Project work encompassing administrative and scientific regulatory activities varying from   writing of technical summaries and filling of databases to compliance work, both for pharmaceuticals and/or medical devices.

-       Draws up CMC documentation for international submissions.

-       Takes part in the review and release of CMC documents in accordance with the applicable procedures.

-       Answers questions from health authorities and coordinates the Agency Response process.

-       Is conversant with relevant, worldwide registration requirements.

-       Makes proposals to the organization with regard to variations of chemical/pharmaceutical documents following questions from authorities. Consults wit the departments involved.

-      Has contacts with other MSD staff of local companies and other sister companies.

-       Sees to planning, coordination and implementation of all the tasks related to his/her project.

Requirements:

-    MSc (Chemistry, Physics, Pharmacy, Analytical Chemistry) or BSc with multiple years of experience

-    Minimum of 1 year registration experience in CMC and/or Medical Devices

-   Good command of written and spoken English.

-   Command of Dutch language is an advantage, but no must.

-   Good editing skills.

-   Has good social skills and is a good team player.

-   Communicative person