At KRKA Spain, a member multinational pharmaceutical company, present in over 70 countries and leader in the production and distribution of medicines, we are looking for a Regulatory Associate to join our team.
Key Responsibilities:
Monitoring and managing product registration regulations
Preparing regulatory activity plans for individual products
Preparing, in cooperation with expert departments at Krka, the registration documentation and translations into local language
Submitting registration documentation to the relevant state institutions in order to be granted marketing authorisation as soon as possible
Conducting registration procedure – supporting the procedure during all phases
Providing on-going information about problems in obtaining marketing authorisation (in writing)
Participating in the organisation and/or realisation of document and text translations into local language
Checking and making corrections of packaging materials written in local language intended for submission to regulatory authorities and before final print
Organising, providing guidance and keeping records on receipt, distribution and archiving of internal and external documentation, information and data




Keeping the data base and documentary records on the registration procedures and distributing relevant data concerning the marketing authorisations
Setting up and maintaining the information system for the entire product range in the territory
Monitoring, analysing and assessing work results
Submitting the pharmacovigilance documentation to the relevant state institutions and transfer of received pharmacovigilance information to the qualified person responsible for pharmacovigilance
Conducting tasks in compliance with rules from the fields of quality assurance, occupational health and safety, and fire safety
All other tasks assigned by superiors and consistent with employee's qualifications and needs of the work process
What we expect from candidates:
Education: University degree in Pharmaceutical Sciences or life sciences
Experience: minimum 1 year experience in registrations
Languages: fluent English (independent user level)
Good organizational and planning skills

Attention to detail and ability to meet predefined deadlines
Adaptability to change

📌 Regulatory Affairs Associate (Madrid)
🏢 Krka
📍 Madrid