International Regulatory Affairs Manager

2 days ago

Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
About the Role

We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Sobi. As a key member of our Global Regulatory Team, you will play a critical role in ensuring the successful development and approval of our innovative therapies for rare diseases.

Key Responsibilities
  • Represent the International Region in Global Regulatory Team and other cross-functional forums, providing strategic guidance on regulatory requirements and changes in assigned countries.
  • 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 Core Dossiers for International, in partnership with cross-functional teams, for assigned products.
  • Develop Regulatory Strategies in assigned countries, in partnership with local Regulatory teams.
  • Manage and Direct all aspects of the successful preparation, submission, and timely approval of marketing applications and post-approval management for assigned countries.
Requirements
  • A University Degree in Life Sciences is required, with 5-7 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.
Attributes
  • A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority, and functional backgrounds.
  • Highly self-motivated and able to drive activities.
  • Excellent communication skills.
  • The suitable candidate should demonstrate the Sobi Values: Care for our patients, for our colleagues, and for our company, Ambition, Urgency, Ownership, and Partnership.
  • Ensure exemplary behavior, ethics, and transparency within the Company and with regulatory agencies.

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