Would you like to be a part of one of the companies “growth engines” and live the future today? Do you perform best where change is daily and the unexpected is considered routine? Do you want a chance to really make a difference?
Business Area Near East (BANE) is representing one of the fastest growing and most dynamic business areas with significant future growth opportunities. It is one of Region International Operation’s (IO) 6 business areas consisting of 11 countries; Turkey, Israel, Iran, Iraq, Jordan, Lebanon, Pakistan, Afghanistan, Syria, Ukraine & Moldova. The business area office is located in Istanbul, Turkey.
They are looking for a Regulatory Affairs Manager for the BANE Office. The position is based in Istanbul, reporting to BANE Clinical, Medical, Regulatory & Quality Director.
About the Department
The BANE Office CMRQ department consists of Clinical, Medical, Regulatory & Quality functions. You will be the Manager of the Regulatory Function which includes 1 direct report. You will drive/ lead regulatory strategy implementation within the Business Area according to International Operation (Zurich) and Head Quarters (Denmark) needs. Provide regulatory support to internal and external stakeholders on a Business Area level and act as an intermediary among the different Affiliates and the International Operation Region/ Head Quarters Regulatory Affairs.
As a Regulatory Affairs Manager you will be drive/Lead regulatory strategy implementation and control product registrations within the BA according to IO and HQ needs. Provide the CMR Director with insights in regulatory matters and initiatives across the BA. Carry the main role in ensuring timely Submission File (STF) updates and preparation for submission within BA countries.
Ensure in-time registration of new products, so that products can be launched according to marketing plans. Ensure that registrations of approved products are maintained and updated/renewed. Set the direction and strategies of the regulatory submissions and tactics for the BA. Ensure availability and implementation of HA’s registration requirements for the countries under direct responsibility of BA. Participate in regional management, planning and monitoring of products’ registration, renewals, labelling/packaging changes and updates. Training & on-boarding of RA in Affiliates.
Fulfil strategic RA input for all markets including markets not covered by IORA Project management for key products/projects. Provide regulatory support and insight to external and internal stakeholders.
Provide feedback to HQRA on changes in regulatory requirements or any other major regulatory issues in the BA. Maintain IT Systems and ensure their correct use
The need to compile RA intelligence in the BA. He/she needs to detect opportunities within the regulatory procedures and process to support Novo Nordisk’s products and business.
You are expected to comply with Novo Nordisk principles, Business Ethics and internal legal laws and to defend company interests & confidentiality.
You hold a degree in an accredited Relevant University in the relevant areas of medicine, pharmacy, biology or chemistry. Minimum 5 years of well-versed experience in Regulatory Affairs.
Understanding of regulatory requirements in countries within the BA would be an added advantage. You have a strong analytical profile, highly flexible and ready for change. You are engaged, dynamic, results-driven, positive mind-set and are able to build relations with people at all levels and have excellent communication skills. Managerial experience is considered as an asset. You must have excellent international network with access to key opinion leaders.
In addition, you must be fluent in both written and spoken English. You are willing to travel up to 20-25% of your working time.
Working at Novo Nordisk
At Novo Nordisk, we strive for excellence. You share the same passion and commitment as our employees in our journey to make a difference to patients’ lives. In exchange, we offer you the chance of a lifetime to work with extraordinary talent and benefit from unmatched opportunities for professional and personal development.
Application deadline: 6th March 2015.