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