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?
The Senior Regulatory Affairs Specialist will be responsible for leading and managing complex regulatory activities related to the authorization and maintenance of generic medicines, hospital medicines. This role ensures compliance with local and international regulations and supports the company's strategic objectives.
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.
- Track supply-limiting variations.
- 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.
- Provide documentation for hospital tenders.
- 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.
E XPERIENCE
- Fluent in spanish and english
- Strong knowledge of applicable legislation related to pharmaceutical regulation.
- Experience auditing new registration dossiers.
- 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.
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🏢 STADA España
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