International Regulatory Affairs Specialist
3 weeks ago
Sobi is a global biopharmaceutical company dedicated to developing and delivering innovative therapies to improve the lives of people with rare diseases. Our team is passionate about making a positive impact and is committed to our core values of Care, Ambition, Urgency, Ownership, and Partnership.
Job DescriptionWe are seeking an experienced International Regulatory Affairs Manager to join our Global Regulatory Team. The successful candidate will be responsible for representing the International region in cross-functional forums, developing regulatory strategies and filing plans, and managing the preparation and submission of marketing applications and post-approval management for assigned countries.
Key Responsibilities- Develop and implement international regulatory strategies and filing plans for assigned products
- Manage the preparation and submission of marketing applications and post-approval management for assigned countries
- Represent the International region in cross-functional forums and provide strategic guidance on regulations and changes in assigned countries
- Support interactions with Health Authorities in assigned countries
- University degree in Life Sciences with 5-7 years of industry experience, including 3 years in Regulatory Affairs
- Experience of regulatory requirements in countries outside the US and Europe
- Excellent written and oral communication skills in English, with knowledge of other languages an asset
- Experience in leading projects and cross-functional teams
- Competitive compensation and benefits package
- Opportunities for professional growth and development
- Collaborative and team-oriented work environment
- Diversity and inclusion
- Meaningful work in a company that makes a positive impact on people's lives
Sobi is an Equal Opportunity Employer and is committed to creating a diverse and inclusive work environment. We believe that our employees are our most valuable asset and are dedicated to supporting their growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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