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.

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Key Responsibilities:

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- 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, xghoner 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.

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

3. Experience: minimum 1 year experience in registrations

4. Languages: fluent English (independent user level)

5. Good organizational and planning skills

6. Attention to detail and ability to meet predefined deadlines

7. Adaptability to change

📌 Regulatory Affairs Associate (Madrid)
🏢 Krka
📍 Madrid