International Regulatory Affairs Manager

at  Sobi

STATISTICS SHOW THAT WOMEN AND UNDERREPRESENTED GROUPS TEND TO APPLY TO JOBS ONLY IF THEY MEET 100% OF THE QUALIFICATIONS. SOBI ENCOURAGES YOU TO CHANGE THAT STATISTIC AND APPLY. RARELY DO CANDIDATES MEET 100% OF THE QUALIFICATIONS. WE LOOK FORWARD TO YOUR APPLICATION!

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

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

Job Description

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

Qualifications

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

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.

• 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 countrie