International Regulatory Affairs Manager

1 month ago

London, United Kingdom Sobi - Swedish Orphan Biovitrum AB (publ) Full time

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
The Manager, Regulatory Affairs International supports our ambitious geographical expansion plans. Sobi is seeking to register some of our existing portfolio into new territories and to register several of our development projects into the international region. This role is key to driving both the Regulatory strategy and execution.
 
Represent International region in Global Regulatory Team and other cross-functional forums, for assigned products
Develop International regulatory strategies and filing plans, in partnership with the Global Regulatory Lead, and country leads, for assigned products in development
Develop regulatory strategies in assigned countries, in partnership with local Regulatory teams
A University Degree in Life Sciences is required with 5 to 7 years of industry experience, of which at least 3 years of experience within Regulatory Affairs (registration, development, maintenance)
Experience of regulatory requirements in countries outside the US and Europe
Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset
Experience from leading projects and cross-functional teams

Ensure exemplary behaviour, ethics and transparency within the Company and with regulatory agencies

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