Regulatory Affairs Product Lead, Türkiye (Fixed-Term Contract)

Job description

This is the opportunity that have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders as our Regulatory Affairs Product Lead in Novo Nordisk Türkiye. This position is a fixed term for 12 months (maternity cover), based in Istanbul, and reports to the Head of Regulatory Affairs and Pharmacovigilance. Your new position: As the Regulatory Affairs Product Lead, you will be responsible for developing the regulatory strategy for innovative products, managing new registration files, technical variations, labelling and safety updates of product registration files and GMP files, in a timely manner and responding effectively to all product registration modifications requested by the HQ/local health authority. You will always act in alignment with our Novo Nordisk Way and demonstrate knowledge of the health care system in Turkey. You will be also responsible for - Conducting the translation, compilation, submission and follow-up related to all NN registration processes - Holding the responsibility for ensuring that the regulatory tasks are completed in compliance with the NN Corporate Quality Procedures, local regulations and business needs. Ac...