stillingsbetegnelse:
Senior Regulatory Specialist Lead for paediatric studies

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 You will be part of RA GLP-1, Obesity and Diabetes Complications, one of the functional areas in Regulatory Affairs. The area is responsible for global strategies to obtain and maintain market authorisations worldwide for new products and for life cycle management activities within treatment of diabetes and obesity. We are 46 dedicated and highly engaged people in four departments, working with projects ranging from early to late stage development and with products already on the market. We are currently looking for a Senior Regulatory Specialist with a scientific background combined with regulatory experience to be responsible for the global regulatory strategy for paediatric investigation plan strategies. The position As Senior Regulatory Specialist you will provide senior expertise in the areas of paediatric investigation plans, nonclinical development, and particularly with focus on nonclinical issues; Comparability and Biosimilars. You will be responsible for optimizing the regulatory aspects of paediatric investigation plans and you will be the expert knowledge of Danish Medicines Agency (DKMA), European Medicines Agency (EMA) and paediatric processes across the Novo Nordisk portfolio. You also will be responsible for identifying trends in the international regulatory environment and ensuring input to new guidelines are pursued. In the area of oral GLP- I, you will be contributing to the development of Health Authority meeting packages and ensuring clear and optimal outcome of the meetings.In addition, you will be responsible for reviewing and challenging critical submission documents, including nonclinical regulatory strategies. You will contribute to international cooperation on paediatric issues within European Federation of Pharmaceutical Industries and Associations (EFPIA) and other trade organisations. In addition, you will work with Novo Nordisk Regulatory Intelligence and Policies on areas within the expertise field. Finally, you will lead project teams or task forces with focus on paediatric issues. Qualifications You must hold MSc or PhD within natural sciences or similar documented scientific qualifications. You should have a strong reputation in the field of Paediatric Investigation Plans and a proven record of extensive global regulatory experience and understanding from the industry (biotech and pharma) or a regulatory agency. Furthermore, you should possess in-depth experience in preclinical development and of handling regulatory documentation for pharmaceutical development. Experience in regulatory affairs dedicated to the therapeutic area is required. You must have experience interacting directly with regulatory authorities on an international scale. As a person you are innovative and science driven with good communication skills. You are well organised, have solid problem-solving capabilities and a winning attitude. You can keep your spirits high even when under pressure. You are a skilled communicator who can cooperate at any organisational level. Finally, you should have command of spoken and written English. Working at Novo Nordisk 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 Christopher Graham at +45 3075 9041. Deadline 15 May 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark