Sobi at a glance
At Sobi, we are transforming life for people with rare diseases. As an international biopharmaceutical company, we provide access to innovative treatments in the areas of haematology, immunology and specialty care.

- Two therapeutic areas – Haematology and Immunology – and a portfolio of products within Specialty Care

- Our extended half-life factor replacement treatments are the most prescribed treatments for haemophilia A and B respectively in several markets

- A strong portfolio of on-market products, and an extensive portfolio of pre-market assets

- An international biopharmaceutical company covering the entire value chain

- We put our focus where we can have the greatest impact, in late-stage research and development, and in patient access and commercialisation

- Revenue of SEK 14.2 bn for the full year 2019 Global Head Office in Stockholm, with offices in more than 30 countries, delivering treatments to patients in more than 70 countries

- Approximately 1,400 employees globally

- The Sobi share (STO:SOBI) is listed in the Large Cap segment at Nasdaq Stockholm.

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Senior Global Regulatory Affairs Managers, Sobi

Opportunitíes to join Sobi that has the vision to become a global leader in rare diseases

Purpose of the position
- To be a professional regulatory support in the development and maintenance of drug products for our entire organization
- Ensure that Regulatory Affairs Department is recognized as a professional partner
- To deliver on time and with the right quality
- To have an expertise ranging from development to marketed products.

Key Responsibilities
- Regulatory responsible for Sobi and / or partner products
- Contact person in relation to the Agency (applications, meetings, etc.)
- Responsible for coordinating and submitting applications and post-marketing obligations to the authorities
- Be an expert on processes, applications and regulatory environment to achieve and maintain marketing authorizations
- Provide generalist comments on the content of regulatory applications
- Develop global regulatory strategies
- Responsible for the CDS and product information
- Be regulatory representative in project and product teams, if applicable
- Cooperate with authorities, partners, regulatory consultants and other departments within Sobi
- Other responsibilities.

Role opportunities
- Work for Sobi a successful growing global rare diseases company with the global headquarters in Stockholm
- Opportunity to work with both development (R&D)- and marketed products
- Optimal size company: solid resources and still dynamic, adaptable and flexible
- Attractive and prioritized therapeutic focus areas
- Attractive company values with a prestigeless culture
- Opportunity to develop within leadership and other valid competency areas
- Work together with highly professional individuals in a team with great collaboration and team spirit.

Position Qualifications and Profile

- Degree in Life Sciences and related
- Solid Regulatory affairs experience from Pharmaceutical Industry or competent authority
- Experience and knowledge of regulatory requirements in markets outside EU and US is an advantage
- Fluency in English, knowledge of other languages is an advantage but not required

Key competencies and personality
- Highly self motivated with the ability to lead, coordinate and finalize RA project and related activities
- Strong team-player with collaborative, respectful and flexible attitude with high engagement (internal and external)
- Able to and enjoys working in a volatile environment with a focus on opportunities and development
- Solid communication skills
- The suitable candidate should demonstrate the Sobi Values: Care for our patients, for our colleagues and our company, Ambition, Urgency, Ownership and Partnership

Magnus Klingberg, Sr Recruitment Consultant PeakSearch, +46(0)70-678 09 92

Jenny Ringh, Sr Recruitment Consultant PeakSearch, +46(0)70-235 81 99