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
Requisitos mínimos
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)
