stillingsbetegnelse: Senior Global Regulatory Lead

jobbeskrivelse:
- Regulatory Affairs - Denmark - Søborg Join a fast-changing environment where engaged people do their best every day to obtain and maintain market authorisations worldwide for all Novo Nordisk medicine across the globe. Our people have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting place to work – but also quite challenging. Are you up for the challenge? About the department RA Oral GLP-1 & Early Diabetes Projects are responsible for development projects within treatment of diabetes and diabetic complications. We are six dedicated and highly engaged employees working in the department. We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams. We are currently looking for a Senior Global Regulatory Lead with a scientific background combined with regulatory experience to be responsible for the global regulatory strategy for diabetes projects in early phase of development. The job As Senior Global Regulatory Lead you will be responsible for the project plan and project execution, provide regulatory input for the project strategy, interact with internal and external stakeholders (e.g. Health Authorities) and represent Regulatory Affairs in project core teams/global project teams. Here, you ensure regulatory deliverables according to agreed timelines, cost and quality. You will assume the role of the challenger who makes an impact, seeks solutions and drive innovations. Furthermore, you will lead global regulatory teams being responsible for regulatory activities for diabetes projects. As a Senior Global Regulatory Lead, you will be overall responsible for submission and approval of clinical trial applications, for driving and coordinating preparation of meeting packages to Health Authorities, conduct Health Authority interactions and for regulatory submissions and approvals. You will interact with medical specialists, researchers and regulators. All in all, you will have a large responsibility and you will have a lot of influence and impact on the way we reach our goals. You will report to the Director of Oral GLP-1 & Early Diabetes Projects and take active part in department related activities, including improvement projects across RA. Qualifications Your background covers an MSc within Biology or Health Science and a relevant PhD or similar documented scientific qualifications. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical and clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have proven strong negotiation skills and a sound business understanding. You also know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues. As a person you are well organised and have solid problem-solving capabilities, just as you show a winning attitude and never loose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can cooperate at any organisational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis. At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment. Contact For further information, please contact Vibeke Hatorp at +45 3075 5697. Deadline 31 January 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark