Global Regulatory Affairs Manager
Driven by research and a passion for science, Ferring Pharmaceuticals is a biopharmaceutical company dedicated to the development of innovative treatments that make a real difference in people’s lives all over the world. Active in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopedics, we develop medicine on the body's own terms. We believe in the power of people and research - and go where ideas and research take us.
Would you like to join us in a challenging and interesting position as Regulatory Affairs Manager within Global Regulatory Affairs, Development Projects?
The Development Projects team in the Global Regulatory Affairs department supports all global projects up to the approval of the product in EU, USA and Japan. The Global Regulatory Affairs Managers play a key role in developing global regulatory strategies, managing scientific advice meetings with authorities and obtaining product registrations in EU, USA and Japan with high quality and competitive labeling.
Reporting to the Associate Director, Development Projects your main responsibilities will be as follows, depending on your level of experience:
- Acting as or supporting the regulatory core team member in development projects, providing regulatory support to project teams including regulatory evaluations and issue management, regulatory input to project planning and conducting project specific regulatory intelligence on an ongoing basis
- Preparing or supporting the preparation of global regulatory strategies in collaboration with relevant departments and stakeholders, identifying and managing regulatory risks, preparing competitive draft labels, preparing regulatory road-maps for global regulatory submissions and developing in-depth knowledge of the relevant projects
- Planning and participating in Health Authority meetings in EU, USA and Japan. You will be driving and leading the preparation of high quality briefing packages and liaise with the Health Authorities, country regulatory managers and experts in order to obtain constructive scientific advices
- Managing compilation, submission and approvals of CTAs and INDs as well as maintaining these CTAs and INDs throughout the product development phases
- Being responsible for or supporting the initial submission and approvals of the Marketing Authorisation applications in the EU and the New Drug Applications in USA and Japan, negotiating competitive product labeling with the Health Authorities
You will be working in international teams providing advice to other functions such as Non-Clinical & Clinical R&D, Pharmaceutical R&D and Pharmacovigilance regarding the regulatory requirements.
The ideal candidate holds a degree in life science or Pharmacy, with at least 3 years’ experience in international/global regulatory affairs, preferably from development projects. Excellent administrative skills as well as good verbal and written communication skills in English are important.
You must have a proactive mind-set combined with the ability to plan, execute and meet deadlines. You are well-organised, have good negotiation skills and the ability to deal with ambiguity. You are a true team player with a constructive attitude to drive results. Last but not least, you are an experienced user of IT (including MS Office), and are keen on working in a multicultural corporate environment.
Further information about the position can be obtained from Associate Director, Global Regulatory Affairs Development Projects, Katrine Rasmussen, mobile: +45 28787674.
Your application and CV in English should be submitted as soon as possible but no later than 4 May 2017, as we will be reviewing incoming applications on an on-going basis.