Profiles Sanidad y Asistencial
Freelance
Completa
Salario competitivo
Our client is an International Scientific and Regulatory Affairs consultancy firm based in Barcelona and Munich.
Regulatory Affairs Officer main responsibilities:
•Overall management of Regulatory Activities in different regions and procedures worldwide (EU, US, RoW):
◦New registrations
◦Life-cycle management
◦Support in CMC / quality
◦Regulatory strategy and assessment in development
◦Authoring of regulatory documentation
◦Critical revision of regulatory documentation
*Write project documentation
•Responsible person for specific client
•Responsible person for communication with authorities
•Responsible for achieving deadlines and overall quality of the work to ensure the best client satisfaction
•Preparation of team-related trainings both internal and external
•Support in business development and marketing activities
•Establish processes and work instructions
According to the project the applicable activities can be done for medicinal products, medical devices, cosmetics, biocides, and other regulated products
Academic degree in sciences
Master in Regulatory Affairs
English high (C1 or equivalence)
Affinity of working with computers: Office, Acrobat
Experience in Regulatory Affairs, also writing documentation
Able to work in team and individually
Available to travel (not very often)
