Senior Regulatory Affairs Associate (Detta uppdrag är avslutat)

On behalf of one of our customers, we are now looking for a Senior Regulatory Affairs Associate, for an 18 months long assignment. In this position you will support the implementation of regulatory operational activities in the Nordics, and coordinate the work with adverse event reports, compliance activities and provide regulatory support for promotional material.

Main responsibilities:

• Develop and maintain knowledge of specific Nordic regulatory requirements and EU regulatory procedures in general.
• Create and maintain internal and external relationships within the Nordic region, to ensure effective communication and efficient implementation of regulatory activities.
• Assist the work with lifecycle management in the Nordics.
• Review and approve promotional materials for the Nordics.
• Coordinate, review and approve ArtWork.
• Provide support to Senior Manager regarding spontaneous adverse event reports received within the Nordics.
• Ensure that medical information enquiries are responded to in a timely manner and that appropriate responses (written or verbal) are provided.

Required qualifications:

• Life Sciences Graduate, ideally in combination with prior experience in product development functions (pharmaceutical development, clinical trials, etc).
• Regulatory Affairs experience, with good knowledge of regulations and guidelines within the Nordic region.
• Experience in cross-functional project teams.
• Conversant with the primary functions of pharmaceutical development, microbiology, toxicology, clinical research and quality assurance.
• Ideally experience of handling of individual safety reports derived from clinical trials and post marketing arena.

To succeed in this role you should have organisational and planning abilities and be an excellent communicator with the ability to collaborate across cultures and cross-functional.

If this sounds interesting, please apply immediately via an external site (follow this link). Applications will be handled continuously.
For further questions, please contact Sara Tomicic +46 709 731 747 or Jens Mogensen, +46 703 002 002.