Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

• Competitive compensation for your work
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

One of Sobi’s four strategic pillars is to “Go Global”. 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
• 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

Education/Learning Experience/Work Experience

• 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

Personal 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 behaviour, ethics and transparency within the Company and with regulatory agencies

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

Why Join Us?

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.