Global Regulatory Operations Manager

Global Regulatory Operations Manager

Sobi

Solna, Sweden

We are now recruiting a Global Regulatory Operations Manager.

In this role, you will be a part of a highly competent team responsible for electronic submissions to regulatory authorities regarding Sobi products. The Regulatory Operations team is part of the Global Regulatory Affairs department, located at Sobi Headquarters in Solna, Sweden. You will collaborate with several functions at the company.

Key Responsibilities:

  • Implementing, upgrading and maintaining systems for import, compilation and archiving of electronic submissions to authorities;
  • Support, planning and preparation of applications in collaboration with the Regulatory Affairs Manager and others who are involved in the preparation of regulatory documents;
  • Knowledge of instructions and guidelines from authorities concerning electronic submissions and ensuring that Sobi submissions are prepared in line with these;
  • Knowledge of new technical solutions such as portals for transmission of submissions to authorities;
  • Contribute to choosing, implementing, developing, maintaining and training the organization in regards to tools that support the operations of Regulatory Affairs, such as eDMS, templates, databases, planning tools etc.;
  • Participating in our continuous improvement activities;
  • Develop and update Standard Operating Procedures (SOPs) related to processes within the team’s areas of responsibility.

Qualifications:

  • University degree in Life Science;
  • Proficiency in IT and MS Word;
  • Experience from work with electronic submissions in the pharmaceutical industry;
  • Excellent verbal and written communication skills in English and preferably also in Swedish.

Personal attributes:

To succeed in this role you must be a be a collaborative team player, organized and thorough. You enjoy working towards deadlines and have a professional, flexible, service-minded approach to your work.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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