Regulatory Technician

STADA Arzneimittel AG; Barcelona; Presencial; EUR 35.000 - 50.000; Jornada completa

Descripción de la vacante

A leading international pharmaceutical company in Barcelona is seeking a Regulatory Technician to monitor regulatory compliance and communicate with health authorities. The ideal candidate should be fluent in Spanish and English, possess strong knowledge of pharmaceutical legislation, and have experience with regulatory software. This full-time position covers maternity leave and supports professional development within a dynamic company.

Formación

• Strong knowledge of applicable legislation related to pharmaceutical regulation.
• Experience with registration and maintenance of medicines.
• Experience working with NeeS and eCTD formats.

Responsabilidades

• Monitor and review new regulations.
• Communicate directly with health authorities.
• Prepare administrative and quality variations.

Conocimientos

Fluent in Spanish

Fluent in English

Knowledge of pharmaceutical regulation legislation

Familiarity with health authority websites

Experience with registration of medicines

Proficiency in regulatory software

Herramientas

Firstdoc

Docubridge

CESP

Descripción del empleo

Regulatory Technician

Barcelona |Spain | Full-time | Maternity leave cover

About Us

At STADA we pursue the purpose of"Taking care of people's health as a trusted partner." All our decisions and actions are driven by our purpose, vision and values. With our wide range of products: Generics, Consumer Healthcare and Specialties, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA, in order to achieve our ambitious goals and shape a successful future for our company. We continually expand our goals in line with our ambition, and we achieve them with passion, commitment and a growth mindset.

Do you want to be part of a successful international pharmaceutical company and grow with us?

Responsibilities

• Monitor and review new regulations applicable to procedures and products.
• Conduct periodic reviews of national and European authority websites.
• Provide local support to central teams for fee preparation, text translations, and artwork.
• Evaluate, prepare, and submit technical information for authority review.
• Communicate directly with health authorities.
• Prepare administrative and quality variations (IA, IAIN, IB, II).
• Handle ownership transfers, name changes, and design updates for new products.
• Support manufacturing transfers and register related changes.
• Prepare safety variations as requested by Pharmacovigilance.
• Prepare and review materials following internal SharePoint/GLAMs procedures.
• Manage internal communications regarding product status.
• Advise other departments on regulatory and compliance matters.
• Maintain Spanish Agency database (RAEFAR), including text editing and error correction.
• Prepare and submit revalidations, temporary suspensions, and cancellations.
• Draft responses to Sunset Clause notifications.
• Support Quality Assurance in audits and documentation management.
• Assist in product release processes by reviewing CoAs and materials.
• Review manufacturing guides and documentation for product launches and maintenance.
• Respond to technical inquiries from patients, pharmacies, and healthcare professionals.

Qualifications

• Fluent in Spanish and English.
• Strong knowledge of applicable legislation related to pharmaceutical regulation.
• Familiarity with national and European health authority websites and regulatory updates.
• Experience with registration and maintenance of prescription and hospital-use medicines via national procedures, DCP, MRP, and CP.
• Proficiency in regulatory software and platforms (e.g., Firstdoc, Docubridge, CESP).
• Experience working with NeeS and eCTD formats.
• Database management (e.g., Register, HESPEC, RAEFAR).
• Knowledge of CEP version reviews and variation submissions.
• Experience in reviewing and approving CCPs from local suppliers.
• Familiarity with change control processes (MOC tool).
• Experience in regulatory support for quality assurance and product launches.

We look forward to receiving your application through our job portal. At One STADA Career Portal you will also find more job opportunities as we are always looking for talent to strengthen our team in line with our growth ambitions.

STADA offers a competitive environment for personal and professional development in a growing company full of opportunities. Our future project requires dynamic and proactive professionals, capable of adding value in a changing environment.

Follow us on LinkedIn to receive our news!