International Regulatory Manager

BaselTemporÀrChemie, Pharma, Biotechnologie2019-07-11Master / UniversitÀt
For a multinational healthcare company we are looking for an experienced

International Regulatory Manager

Your challenges

•Provide expert knowledge on regulatory requirements and evnironment for assigned international countries
•Accountable for clinical trial application strategy and support to Clinical Trial Regulatory Management group for dossier dispatch
•Able to collaborate with global and local stakeholders to generate and deliver the product strategy, ensuring timely submission of regulatory applications
•Lead and plan Health Authority Meetings and respond to Health Authority questions and provide authoring support as needed
•Partnering with the Global Regulatory Leader and EU and US Partners to discuss and align on regulatory activities
•Develop and execute objectives and plans towards aligning one global regulatory voice/outlook to international affiliates
•Participating in projects and initiatives outside of the core scope of International Regulatory Manager responsibilities

Your skills

•Minimum of 5 years of experience in International Drug Regulatory Affairs
•University Degree, preferably in a scientific discipline
•Knowledge and experience of global regulatory processes
•Good practical experience of contacts with health authorities

Your horizons

•We offer an attractive package with competitive salary.
•Professional and personal development
•Work life balance
•A dynamic and pleasant work location

Your contact

Lisa Bianculli, Recruitment Consultant, looks forward to answer your questions by phone +41 58 233 2102.

You can apply directly online.