Regulatory Affairs Manager

Job description

Do you want to set the Regulatory Strategy for Novo Nordisk products and projects? Then you should join a fast-changing environment. 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. This is an exciting opportunity to join Novo Nordisk Turkey as Regulatory Affairs Manager, based in Istanbul, and reports to the Head of Regulatory Affairs and Pharmacovigilance. Your new position As the Regulatory Affairs Manager, you will be responsible for developing regulatory strategies for innovative products, managing internal&external stakeholders, representing Novo Nordisk in industry associations and leading key strategic initiatives. You will be also expected to manage new registration files, plan technical variations, renewals, labelling and safety updates of product registration files and GMP files, in a timely manner and respond effectively to all product registration modifications requested by the HQ/local health authority. You will be also responsible for Holding the responsibility for ensuring that the regulatory tasks are completed in compliance with the NN Corporate Quality Procedures, local regulations and business needs. Conducting the translation, compilation, submission and follow-up related to all NN registration processes Accompanying GMP inspection with inspector and conducting all GMP process and communication with stakeholders for assigned manufacturing sites. Being a coherent business partner for the business units, initiate effective cross-functional collaborations for fast regulatory approvals, creating and keeping competitive labels. In addition, you will represent Regulatory Affairs in internal brand teams by providing input on strategy and actions. Monitoring competitive intelligence on relevant therapeutic areas and local environment for developments in regulations and providing relevant information to key internal and external stakeholders and advising on necessary actions about changing regulations. Your new department The Medical, Regulatory (MR) department provides timely, accurate, and updated services to support Novo Nordisk in all therapeutic areas. The Medical and Regulatory Department is a team of skilled and committed specialists within medical, regulatory, and safety areas. Regulatory Affairs Unit is responsible for local strategies to obtain and maintain marketing authorisations for Novo Nordisk’s new products and life cycle management activities such as new indications and GMP processes. We aim to be the best Regulatory Affairs unit in the global pharma industry, being true business partners and continuously improving our performance while offering our people a great place to work. Your skills & qualifications You are expected to hold a university degree in Pharmacy, Chemical Engineering, Chemistry, Biology or Medical. You have minimum 8-10 years of proven experience in regulatory affairs in pharma industry and you should have advanced level of written and spoken English and Turkish. Further sought-after skills include: The ability to manage multiple projects and submissions simultaneously and prioritize your workload to meet business deadlines. Excellent communication and stakeholder management abilities, effective time-management skills, and a can-do mindset. Strong analytical capabilities, strategic thinking, and the eagerness to learn and influence the organization to move forward. Knowledge of ICH guidelines, EU regulations, and international pharmaceutical regulatory standards. Strong knowledge of the requirements of the Turkish Medicines and Medical Devices Agency and Turkish pharmaceutical legislation. Proficiency in Microsoft Office and relevant regulatory databases or document management systems. Aligning with our Novo Nordisk Way Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. What We Offer There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. Deadline Apply before 25 September 2026. Applications are reviewed on an ongoing basis. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.