- Ensure Regulatory Compliance of the products manufactured in Alcobendas.
- Review of Specifications, Manufacturing Tickets, Stability protocols, Validation protocols, Pharmacopeias etc.
- Quality Agreements, Site Master File.Change controls
- Provide CMC Regulatory affairs support to manufacturing site operations for Existing/New Products.Regulatory dossiers, Variations, Renewals, Source Changes.
- TrainingGain and maintain deep knowledge of key CMC Regulatory legislation (EU, ICH and major markets e.g., Australia, Canada, USA etc).
Education and Experience
- University Degree in Health Sciences, preferably in Pharmacy.
- High level of English written and spoken (C1 level).
- Master in the Pharmaceutical Industry is desirable.
- Interpersonal skills: team work, customer orientation (internal/external), critical decision taking, oral and written good communication, listening attitude, leadership, problem resolution ability. Organizational skills: ability to prioritize objectives, focusing on priorities and business needs.
- Methodic style and Archiving is key.
- Technical skills: knowledge on Regulatory processes and legislation.
- IT: user level on Microsoft tools, knowledge on IT systems that govern the Regulatory processes.