• Pharmaceutical products
• Valles Occidental

¿Dónde vas a trabajar?

International Pharmaceutical Company

Descripción

• Ensure all regulatory submissions align with EU/Spanish legislation, guidelines, and timelines, meeting business objectives.
• Lead selected National Procedures (NPs), Mutual Recognition Procedures (MRPs), Decentralized Procedures (DCPs), and Repeat-Use Procedures (RUPs) on behalf of the MAH in EU, coordinating with Regulatory Authorities across EU countries, including Spain.
• Prepare, review, publish in eCTD format, and submit dossiers for new product registrations, variations, renewals, and other regulatory filings to Spanish Health Authorities (AEMPS) and other EU Agencies.
• Perform evaluation of the dossiers within in-licensing process
• Serve as the primary point of contact for Spanish Regulatory Agency (AEMPS).
• Monitor and ensure compliance with post-approval regulatory requirements, including pharmacovigilance commitments and periodic updates.
• Provide regulatory support for product launches and marketing activities in Spain.
• Maintain accurate and up-to-date records of all regulatory activities and submissions.
• Prepare and review the content of Summaries of Product Characteristics, patient information leaflets, and product labelling.
• Coordinate the creation and revision process for artworks (package leaflets, immediate and outer packaging labelling).
• Participate in budgeting processes related to regulatory activities.
• Provide strategic regulatory input during the development of registration strategies at the Group level.
• Contribute to defining and harmonizing RA processes and operations across the Group.
• Collaborate with affiliates, partners, contractors, and manufacturers to ensure compliance, smooth operations, alignment, and consistency in regulatory practices.
• Support pricing and reimbursement activities/submissions.
• Prepare/update Module 3 of the dossier for medicinal products.
• Prepare technical files for Notified Body Opinion procedures for drug-device combination products.

¿A quién buscamos (H/M/D)?

• Master's degree in Pharmacy, Biotechnology, Life Sciences, or a related field.
• Minimum 5 years of experience in Regulatory Affairs within the pharmaceutical industry, with at least 2 years focused on EU regulatory activities.
• Excellent knowledge of Spanish and European regulations in the field of pharmaceutical law
• Experience in Global Regulatory Affairs (MENA, Asia, etc.)
• Knowledge of food supplements and medical device, drug-device combination regulations.
• Basic knowledge of Chemistry, Manufacturing, and Controls (CMC) requirements
• General knowledge of MS Office (Word, Excel, Power Point)
• High English level and Spanish

¿Cuáles son tus beneficios?

• Hybrid model: 3 days office (Valles Occidental) / 2 days home