Regulatory Affairs Associate

Krka; Madrid; On-site; EUR 28,000 - 36,000; Full time

Job summary

Krka Spain is seeking a Regulatory Associate to join our team. The role involves monitoring product registration regulations, preparing regulatory activity plans, and coordinating documentation translations with Krka experts to secure timely marketing authorisation.

The candidate should have a university degree in pharmaceutical sciences or life sciences, at least 1 year of registrations experience, and fluent English with strong organizational skills.

Qualifications

• University degree in Pharmaceutical Sciences or life sciences.
• Minimum 1 year experience in registrations.
• Fluent English (independent user).
• Good organizational and planning skills.
• Attention to detail and ability to meet predefined deadlines.
• Adaptability to change.

Responsibilities

• Monitor and manage product registration regulations.
• Prepare regulatory activity plans for individual products.
• Prepare and translate registration documentation into local language with Krka experts.
• Submit registration documentation to state authorities to obtain marketing authorization.
• Conduct registration procedures and support all phases.
• Provide written updates on problems obtaining marketing authorization.

Skills

Regulatory experience

Fluent English

Organizational skills

Education

University degree in Pharmaceutical Sciences

Job description

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