Job ad: Regulatory documentation Specialist

Regulatory documentation Specialist

Our Medical team at Nykode is looking for an individual to join as Regulatory Documentation Specialist in either Oslo or Copenhagen.

The role holds a pivotal role for the regulatory team by being responsible for key administrative tools and documents as well as process optimisation related to regulatory activities and oversight.

The responsibilities of this position include:

• Assist the regulatory team in preparing and coordinating regulatory submissions such as clinical trial applications, IND submissions, orphan and paediatric submissions, Health Authority meeting requests and briefing package submissions in collaboration with clinical CRO’s and regulatory vendors (e.g. eCTD publisher)
• Provide support to regulatory submissions, including coordination of review and finalisation of documents across functional areas
• Manage certain outsourced regulatory activities, e.g. in connection with eCTD compilation