Lrr - Senior Associate Regulatory Affairs (Barcelona)

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