vacature regulatory-affairs

RA Compliance Manager (1,0 FTE)

Derks & Derks Detachering

Temporary position to review promotional materials till the end of the year in the pharmaceutical industry

Offer
  • diverse job within a pharmaceutical company
  • interesting because of the specialist work in regulatory affairs
  • temporary contract with the possibility to extend
Organisation

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has a tight line all around the world. For the regulatory department they look for support. Therefore, they would like to meet an experienced RA Compliance Manager with project management skills.

Position

As a RA Compliance Manager, you will support EMEA Affiliate Management & Support and the Affiliate RA teams to implement the revised global policy. In specific you will work on the Global Policy for Creation, Review, and Approval of Materials Utilized for Promotion. With the new policy RA becomes responsible for the review of product claims being consistent with the registered product information. You will responsible to perform these reviews for a certain set of promotional materials. Furthermore, you will support RA to become responsible for reviewing promotional materials in accordance with applicable regulations and internal company processes and policies (code compliance review). In this position you will be working together with the local affiliates and your co-workers. You report to the manager of the department.

Profile
  • at least a bachelor’s degree
  • more than 5 years of working experience in reviewing promotional materials
  • experience within the pharmaceutical industry
  • proven experience in regulatory, medical or compliance
  • proven affinity with project management
  • good communication skills to level with all layers of the organisation
Response

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-059-DD, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

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