RA Manager & LQPPV

• Pharmaceutical products
• Valles Occidental

International Pharmaceutical Company

• 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.


• Act as the Local Qualified Person for Pharmacovigilance (LQPPV) for Spain on behalf of the MAH.


• on behalf of the MAH.

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

• 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