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Global Regulatory Affairs Lead

2 months ago

Stockholm, Stockholm, Sweden Sobi Full time
About the Role

We are seeking a highly skilled and experienced Global Regulatory Affairs Lead to join our team at Sobi. As a key member of our organization, you will be responsible for providing strategic regulatory leadership and guidance to support the development and approval of our rare disease therapies.

Key Responsibilities
  • Regulatory Strategy and Planning
    • Develop and implement global regulatory strategies to support the development and approval of our rare disease therapies
    • Collaborate with cross-functional teams to ensure regulatory compliance and alignment with business objectives
  • Regulatory Affairs Leadership
    • Provide regulatory leadership and guidance to support the development and approval of our rare disease therapies
    • Lead and manage regulatory teams to ensure effective execution of regulatory strategies
  • Regulatory Interactions and Communications
    • Develop and maintain relationships with regulatory authorities and industry partners
    • Communicate regulatory information and updates to internal stakeholders
  • Regulatory Compliance and Risk Management
    • Ensure regulatory compliance with all applicable laws and regulations
    • Identify and mitigate regulatory risks to support business objectives
Requirements
  • Education and Experience
    • Advanced degree in a life science or related field
    • Minimum 8 years of experience in regulatory affairs, with a focus on rare disease therapies
  • Skills and Qualifications
    • Expertise in regulatory affairs, with a focus on rare disease therapies
    • Strong leadership and communication skills
    • Ability to work in a fast-paced environment and prioritize multiple tasks
About Sobi

Sobi is a global biopharmaceutical company dedicated to developing and delivering innovative therapies to improve the lives of people with rare diseases. We are committed to making a positive impact on the lives of our patients and their families.

We offer a competitive benefits package, including a comprehensive health insurance plan, 401(k) matching program, and generous paid time off. Our company culture values diversity, equity, and inclusion, and we are committed to creating a workplace that is welcoming and inclusive for all employees.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking to make a difference in the lives of people with rare diseases, we encourage you to apply for this exciting opportunity.