Sosu-job i Storkøbenhavn
Regulatory Professional in Regulatory Affairs – temporary position
To support our world-wide regulatory submissions, we are seeking a Regulatory Professional to join the Regulatory Affiliate Support department in a temporary position for a period of 12 months.
About the department
Regulatory Affiliate Support is part of the Submission Management area in Regulatory Operations, located in Søborg, Denmark. We work closely with stakeholders across the organisation both within headquarters in Denmark and India as well as affiliates worldwide. We are a team of 10 highly motivated and engaged employees who are responsible for the additional regulatory documents process supporting global submissions.
Your main responsibility as a Regulatory Professional is to be central point of contact for affiliates and provide them with additional registration file documentation such as export certificates and statements as well as product samples for submissions to health authorities worldwide. One of your focus areas is to support global manufacturing site transfers ensuring timely submissions of these.
You will be interacting with many stakeholders in the company and with health authorities in order to provide responses and documentation to support the submissions. In addition you will be planning, coordinating incoming reques...