REGULATORY AFFAIRS PROFESSIONAL
Responsibilities / Main Tasks
- Coordination, preparation, and submission of CMC documentation for Marketing Authorization Applications / Variations / Renewals of products manufactured at site Madrid, in compliance with local or regional requirements in different countries, including responses to questions from regulatory authorities and involvement in defining the regulatory strategies.
- Coordination and preparation of CMC documentation for IMPDs for Clinical Trial Applications with products manufactured at site Madrid.
- Handling the national phase of variations / MAAs submitted by European procedures (MRP/DCP) – incl. fee payment, translation to local language of the product information (SmPC, PL, Labelling), change requests for printed packaging materials – and follow-up with AEMPS until approval.
- Review of change control requests, including assessment of regulatory impact.
- Writing SmPCs, PL, labels for Named-Patient Products (NPP) and Abridged SmPCs for promotional materials.
- Applying for Certificates of Pharmaceutical Products (CPP) / special licenses / Free Sale Certificates / other documents and handling the subsequent legalization process.
- Handling product launch notifications of registered products & applications for yearly maintenance of registered products in Spain, via AEMPS' portal.
- Archiving all documentation concerning MAAs/variations submitted and authorized in ALK's electronic systems and corresponding database, ensuring they are kept up to date.
- Keeping abreast of regulatory procedures and changes and providing regulatory support to other departments.
- Participating in strategic international projects.
Requirements / Education
- Bachelor of Science / Master's degree in Health Sciences (Pharmacy, Biology…).
- Master's Degree in the Pharmaceutical Industry recommended
- Specific regulatory affairs courses recommended
- ≥3 years as Regulatory Affairs Professional in a pharmaceutical company (preferably Multinational).
- Experience in international projects will be an asset
- Knowledge of the European Regulatory environment (procedures, legislation, guidelines, CTD, etc.).
- Fluent in English; experience in writing technical/scientific documentation in English.
The candidate must be:
- Organized, methodical and pay attention to detail
- Collaborative; work well as a team, but also on his/her own
- Problem-solving attitude
- Not afraid of challenges
- Good communication skills (especially in writing)
Contact and application
If you need further information about the position, please contact our HR Development Consultant, Leticia García, LGJES@alk.net but please do not send your CV via e-mail due to GDPR rules
We look forward to hearing from you.
Comunidad de Madrid
Teléfono: +34 913276100