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International Regulatory Affairs Manager

2 months ago

Stockholm, Stockholm, Sweden Sobi group Full time
Job Summary

We are seeking a highly skilled Global Regulatory Affairs Specialist to join our team at Sobi. As a key member of our Global Regulatory Team, you will be responsible for developing and implementing international regulatory strategies and filing plans for assigned products.

Key Responsibilities
  • Represent the 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.
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.
  • 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 behaviour, ethics and transparency within the Company and with regulatory agencies.
About Sobi

Sobi is a global biopharmaceutical company dedicated to rare diseases. We are committed to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our team is passionate about making a positive impact and we are looking for like-minded individuals to join us.

We offer a competitive benefits package and a collaborative and team-oriented environment. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.