stillingsbetegnelse: Regulatory Project Manager

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Novo Nordisk Regulatory Affairs is seeking an experienced Regulatory Project Manager for our team in Søborg, Regulatory Affairs Victoza®. If you thrive in a dynamic and challenging environment with focus on regulatory strategy and execution, this job offers you the opportunity to be responsible for the regulatory management of the Victoza® LEADER® cardiovascular outcome trial. About the department Regulatory Affairs Victoza® works with Victoza® our blockbuster GLP-1 agonist for treatment of type 2 diabetes and with other liraglutide projects for treatment of diabetes. Our responsibilities include outlining the regulatory strategies, interacting with regualtory authorities and managing the regulatory submissions to obtain and maintain marketing authorisations worldwide for Victoza®. We have a project centric organisation and you will work in cross-functional teams. Our key external stakeholders are the regulatory authorities. The job You will be responsible for managing the regulatory activities related to the Victoza® LEADER® cardiovascular outcome trial including outlining the regulatory strategies, managing the regulatory submissions and securing the approvals of a competitive label world wide. You will be part of a highly dedicated regulatory team that will secure high quality regulatory documents and ensure compilation of the dossiers supporting the Victoza® LEADER® submissions. On a daily basis, you will work closely with our medical, marketing and safety departments, as well as with Novo Nordisk affiliates and regulatory authorities around the world. Furthermore, you will need to understand the diverse needs of the people you work with, so you can facilitate effective collaboration among a wide range of parties, even in the face of difficult challenges. You will work in a fast-paced environment where no days are alike. Tight deadlines, cross-functional collaboration and communication will be part of your busy workday. You will be expected to take the regulatory lead and to provide regulatory options to support decision making in the LEADER® core team. We trust in your sense of responsibility and commitment to deliver excellent results and we offer a flexible working environment. Qualifications Youhold a master’s degreein pharmacy, biology or similar. In addition, you have at least three to five years of broad regulatory experience including managing major submissions and successful interactions with key agencies e.g. FDA and CHMP. You have a proven track record in obtaining competitive labels preferably for a diabetes product. Documented experience with cardiovascular outcome trials and in-depth therapy area or disease understanding within diabetes and cardiometabolic diseases would be a distinct advantage. In addition, you have demonstrated that you can plan, keep track on timelines and ensure that the regulatory team delivers regulatory dossiers of high quality. You are expected to be a proactive problem solver who ensures a smooth working process for the world wide Victoza® LEADER® submissions. The job requires that you are excellent at managingkey stakeholder relations across Novo Nordisk globally and that you bring a can-do attitude and a good sense of humour even when the pressure is on. You have successfully worked in international teams respecting the contribution of everyone. The job requires proficiency in English, excellent communication, coordination and planning skills. Learn more about us: novonordisk.com/RD-careers Novo Nordisk is the world leader in diabetes care. Our success is built on more than 90 years of innovation and commitment to patient-care. We combine world–class scientific, pharmaceutical and clinical experience with the highest ethical standards to continue to improve the quality of life of millions of patients across the world. Contact For further information, please call Lene Melchi

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark