International Regulatory Affairs Manager

International Regulatory Affairs Manager

Sobi

Basel, Switzerland

Job Description

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.

Key responsibilities

• 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
• Plan and create a core dossier for International, in partnership with cross-functional teams, for assigned products
• Develop regulatory strategies in assigned countries, in partnership with local Regulatory teams
• Manage, plan and direct all aspects for the successful preparation, submission and timely approval of marketing applications and post-approval management for assigned countries
• Provide strategic guidance on regulations and changes in assigned countries
• Support interactions with Health Authorities in assigned countries

Qualifications

• 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

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