Director, Regulatory Affairs, International

Director, Regulatory Affairs, International

Sobi

Sweden

Role & Function

One of Sobi’s four strategic pillars is to “Go Global”. To support our ambitious geographical expansion plans, the Global Regulatory Affairs department is looking for a Director to join the growth journey. 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 will be key to driving both the Regulatory strategy and execution.

Key Responsibilities

• Represent International region in Global Regulatory Teams and other cross-functional forums, for assigned development projects;
• Develop International regulatory strategies and filing plans, in partnership with the Global Regulatory Lead, and country leads, for assigned development projects;
• Plan and create a core dossier for International, in partnership with cross-functional teams, for assigned development projects;
• Develop regulatory strategies in assigned region, 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 region;
• Provide strategic guidance on regulations and changes in assigned region;
• Support interactions with Health Authorities in assigned countries;
• Develop and update key internal processes to ensure efficient ways of working;
• Coach, mentor and lead a team to ensure objectives are successfully delivered to time and quality.

Qualifications

• A University Degree in Life Sciences is required with 10 years of industry experience, of which at least 8 years of experience within Regulatory Affairs (registration, development, maintenance);
• Experience of regulatory requirements in countries outside of the US and Europe;
• Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset;
• Experience of leading projects and cross-functional teams;
• Travel requirements: 10 to 20%.

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;
• 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.

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