Regulatory Professional II Full-time Job

Apply now- At Novo Nordisk, we assure you will experience the best. About the department Regulatory Affairs play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs are involved throughout all phases of product development and roll-out. Our people in Regulatory Affairs come from many different academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities. The Position As a Regulatory Professional, responsibilities include planning, preparing, and submitting high quality files to the health authorities achieving fast approvals. You will work as an integrated part of global cross-functional teams with stakeholders ranging from safety, medical affairs, commercial to our Novo Nordisk affiliates worldwide.An ideal candidate will be further responsible for preparation and delivery of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory approvals globally. Demonstrating subject matter expertise within regulatory science including but not limited to profound knowledge about regulatory processes and activities related to global Life Cycle Management activities is expected. Compile, review and submit pre-meeting packages for authority meetings. Handle post approvals, query response, change requests from QA. Submission of regulatory files, response to health authorities and maintenance of marketing authorizations worldwide. Pharmacovigilance documentation like Drug Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Investigation Brochures, Clinical Trial Reporting and clinical trial applications. Handle Life Cycle Management (LCM) of the product, keeping the product live- clinical file protocols and Interim study reports.