Industria Farmaceutica jobs in Spain
Operations Project Integrations Specialist
Actual Talent
Meeting Planner (Receptivo) - Barcelona
Carlson Wagonlit Travel (Hauptsitz Deutschland) / CWT Beheermaatschappij B.V. Deutschland
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AstraZeneca
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Microbiological Control Technical Manager (Validation)
Grifols, S.A
Desenvolupador/a Farmacèutic Nutraceutic — Planta Pilot
[Dades de l empresa ocultes] * Verificada *
Product Manager — AI-Driven Study Cost Optimization
AstraZeneca
Product Manager, Study Design & Planning Cost Module - Evinova
AstraZeneca
Strategic BD Manager - AI for Clinical Trials
Legit.Health
Nutraceutical Formulation Lead - Scale-Up & Innovation
Pharma New Talent
Strategic Planning & Market Excellence Lead
Teva Pharmaceuticals
Business Development Manager: Ai & Clinical Research (Medtech Saas)
Legit.Health
Analista de Control de Calidad Inmunoquímico (ELISA)
Grifols
Business Excellence Manager - Innovative Medicines
Teva Pharmaceuticals
Farmacéutico Hospitalario FIR | Jornada Completa
Endivo Consulting
Surgical & MedTech Marketing Product Manager
Johnson & Johnson
Regulatory Affairs Technician
Job summary
A leading pharmaceutical company in Sant Cugat del Vallès is seeking a qualified regulatory affairs specialist. Responsibilities include studying scientific documents, ensuring compliance with legal authorities, managing product trials, and negotiating with regulatory bodies. The ideal candidate should have experience in Pharma, OTC, and pharmaceutical registration, and demonstrate strong analytical skills and attention to detail to successfully navigate the complexities of regulatory standards.
Qualifications
- Experience in preparing documentation and ensuring compliance with regulations.
- Ability to manage product trials and regulatory inspections efficiently.
- Fluency in writing clear product information for various audiences.
Responsibilities
- Studying scientific and legal documents.
- Gathering and organizing information in various formats.
- Maintaining familiarity with company product ranges.
- Keeping up to date with changes in regulatory legislation and guidelines.
- Writing user-friendly product information leaflets and labels.
Skills
- Studying scientific and legal documents
- Gathering, evaluation, organizing, managing and collating information in a variety of formats.
- Ensuring compliance with regulations set by the legal authorities as Medicines and Medical devices Regulatory Agency (AEMPS)
- Maintaining familiarity with company product ranges
- Planning, undertaking, and overseeing product trials and regulatory inspections
- Keeping up to date with changes in regulatory legislation and guidelines
- Analyzing complicated information, including clinical trial data
- Offering advice about company policies, practices and systems
- Obtaining marketing permission
- Outlining requirements for labelling, storage and packaging
- Using a variety of specialist computer applications
- Liasing and negotiating with regulatory authorities
- Providing advice about regulations to manufacturers/scientists
- Writing comprehensible, user-friendly, clear product information leaflets and labels
- Ensuring that quality standards are met and submissions meet strict deadlines
- Preparing documentation
- Experience in Pharma, OTC and pharmaceutical register*
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.