Position

Regulatory Affairs Associate – International Markets

Location

Barcelona

Experience

Minimum 4 years in similar regulatory affairs roles.

Responsibilities

• Review and interpret regulatory regulations related to products and procedures, ensuring communication through company policies.
• Collect and review documentation for new product submissions to local licensees/affiliates.
• Review dossier compilation for Module 1 of new marketing authorization requests.
• Submit registration applications and follow up with licensees/affiliates to approval and product launch.
• Prepare and review responses to deficiency letters from health authorities.
• Prepare and review documentation for administrative/quality and safety variations.
• Act as regulatory representative to internal stakeholders and serve as regulatory liaison throughout the product life cycle.
• Collect and revi...