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 (Alcobendas)
🏢 KRKA Spain
📍 Alcobendas