Regulatory Affairs Associate: Global Product Registrations

Krka; Madrid; Sur place; EUR 28 000 - 36 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory experience

Fluent English

Organizational skills

Formation

University degree in Pharmaceutical Sciences

Description du poste

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.