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: 1.

Education:
University degree in Pharmaceutical Sciences or life sciences 2.

Experience:
minimum 1 year experience in registrations 3. Languages: fluent English (independent user level) 4. Good organizational and planning skills 5. Attention to detail and ability to meet predefined deadlines 6. Adaptability to change

📌 Regulatory Affairs Associate (Madrid)
🏢 Krka
📍 Madrid