Regulatory Affairs Professional will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The holder of this position will organize regulatory information, track and control submissions and provide guidance and advice to internal stakeholder.

The Regulatory Affairs Professional will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements. The holder of this position will organize regulatory information, track and control submissions and provide guidance and advice to internal stakeholder.

Main Responsibilities & Tasks:

Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategiesProvide expert regulatory input to strategic decision making; including review, prioritization, and external communicationsSupport the development and establishment of policies and standardsCoordinate successful submissions and approval of applicationsPlan, undertake and oversee regulatory inspectionsLiaise and negotiate with regulatory authoritiesProvide advice about regulations to relevant stakeholderKeep up-to-date with changes in regulatory legislation and guidelines

Qualification & Skills:

Bachelor degree in a science or related field5+ years relevant experience within the Regulatory Affairs discipline (Biotech Pharma, Device)Deep knowledge of the relevant Regulatory requirementsThorough understanding and demonstrated ability to apply Regulatory guidelines/regulationsability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resourcesProven analytical skill and technical/scientific competenceAttention to details and ability to appropriately assess risksStrong initiation and organizational skillsExcellent communication skills, with ability to influence others and negotiate successful outcomesProactive, quick learner and independent worker able to effectively multi-task in a strongly growing organisationTeam-player, able to positively influence Team members at all levelsFluent in English

About Sartorius 

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. 

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application. 
www.sartorius.com/careers