Senior Regulatory Affairs Pharma (MARESME)

The selected candidate must meet the following requirements: Essential requirements

• Bachelor's Degree or Degree in Health Sciences, Pharmacy, Biology, Chemistry, or similar.
• Minimum of 3-5 years of experience in Regulatory Affairs within a manufacturing pharmaceutical industry.
• Essential experience managing regulatory activities associated with marketed products and GMP production plants.
• Experience in:
• Maintenance of registration dossiers.
• Regulatory variations.
• European MRP/DCP procedures.
• Implementation of regulatory changes in manufacturing.
• Interaction with Production, QA, and QC.
• Native Catalan.
• Advanced English (B2).

We will especially value profiles from:

• Pharmaceutical manufacturers of parenteral solutions.
• Production plants for intravenous solutions, sera, or sterile products.
• GMP environments with high regulatory requirements.
• Regulatory Affairs departments with high interaction with industrial operations.
• Manufacturing companies of products intended for the hospital environment.

• Salary between €50,000 and €60,000 gross per year, depending on experience provided.

We offer:

• Joining a leading multinational company in the healthcare sector, with a strong international presence and a solid track record in the hospital field.
• Strategic position within a plant specialized in the manufacture of saline solutions and other essential products for the hospital environment.
• Highly regulated environment where Regulatory Affairs has close interaction with Production, Quality, and international teams.
• Opportunity to develop a comprehensive vision of the regulatory life cycle of marketed products.
• Participation in international projects and direct contact with health authorities and global regulatory teams.
• Permanent contract.
• Hybrid work model with 1 remote day per week.
• Meal voucher of €11 per day.
• Schedule from 08:00 to 17:00, with flexibility for arrival and departure.
• Vacations and social benefits according to the General Collective Agreement of the Chemical Industry.

To guarantee the regulatory maintenance and compliance of the medicines and medical devices manufactured at the plant, with a special focus on saline solutions and products for hospital use, ensuring permanent alignment between production processes, technical documentation, and authorized registrations.

• Strategic position within a plant specialized in saline solutions.

Your main functions will be:

• Maintain up-to-date medicinal registration dossiers through the preparation, submission, and follow-up of national and European regulatory variations (MRP/DCP).
• Act as the regulatory reference for the plant, guaranteeing alignment between production activity and the status authorized in the health registrations.
• Create and maintain product specifications, ensuring their adequacy to the approved dossiers and manufacturing processes.
• Review and approve specifications for raw materials and packaging materials used in production.
• Proactively identify deviations or potential GAPs between manufacturing, quality control, and regulatory documentation, leading the necessary actions to ensure regulatory compliance.
• Coordinate the implementation at the plant of approved regulatory variations, guaranteeing the update of procedures, specifications, and associated documentation.
• Prepare and maintain technical documentation for medical devices, including risk management documentation, post-market surveillance, and regulatory compliance.
• Manage renewals, revalidations, regulatory updates, and reports required by health authorities.
• Prepare and review technical data sheets, leaflets, and packaging materials in accordance with current legislation.
• Provide regulatory support to international subsidiaries and collaborate with global teams for products manufactured at the plant.
• Actively participate in audits, regulatory inspections, Product Quality Reviews (PQR), and continuous improvement projects.
• Stay permanently updated on national and European regulations applicable to medicines and medical devices.

• Location in the Maresme area; residence in Maresme or Vallès is required due to proximity to the workplace.