Global Regulatory Affairs Managers to Sobi

Global Regulatory Affairs is looking for Global Regulatory Affairs Managers to our Teams working with Haematology and Immunology. In this role you will have product responsibility for product on the market, be involved in geographic expansion activities and support developing projects.

Key Responsibilities include:

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
Be regulatory representative in the Core Projects/Products Teams, if applicable   
Cooperate with authorities, partners, regulatory consultants and other departments within Sobi
Develop and update regulatory SOPs, participate in operational excellence work
Provide regulatory input to project and product forecasts


Qualifications:

The right candidate fulfills the following qualifications:

University degree in Life Sciences
Experience from pharmaceutical industry or competent authority (registration, development, maintenance). Preferably more than 3 years.
Regulatory Affairs knowledge
Fluency in English and preferably Swedish, other languages is an upside but not required


Personal attributes:

Strong team-player with collaborative, respectful and flexible attitude and high engagement.
Able to collaborate with different parties both external and internal
Able to and enjoys working in a volatile environment
Highly self-motivated and able to drive activities
Excellent communication skills


The suitable candidate should demonstrate the Sobi Values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership.

The position is based in our Head Office Solna.

If you are interested in applying for this position, please submit your CV and cover letter through our webpage www.sobi.com career /open positions