Regulatory Affairs Specialist — Dossier & Launch Support

NL23 (FCRS = NL023) Sandoz B.V; Almere; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Sandoz B.V. is seeking a Regulatory Affairs Specialist to manage registrations, product information, and artworks for current and future products.

You will combine meticulous attention to detail with strong planning and collaborate with a wide range of internal and external stakeholders. You will ensure compliance with registration requirements, coordinate document translations, and support audits, inspections, and regulatory submissions across the product lifecycle.

Qualifications

• Detail-oriented and proactive in a highly regulated environment.
• Ability to work independently and align with others when needed.
• Experience in pharmaceutical regulatory affairs preferred.

Responsabilités

• Maintain registration dossiers and coordinate translations of documents including PI and SmPCs.
• Manage product artworks and ensure packaging texts comply with registered information.
• Respond to health authority questions and support audits/inspections.
• Support product launches and site transfers, and provide RA support to internal/external stakeholders.

Connaissances

Regulatory Affairs

Stakeholder Management

Attention to detail

Planning

Formation

Biomedical sciences / Pharmacy / Pharmacology

Outils

Microsoft Office

Description du poste

Sandoz B.V. is seeking a Regulatory Affairs Specialist to manage registrations, product information, and artworks for current and future products.

You will combine meticulous attention to detail with strong planning and collaborate with a wide range of internal and external stakeholders. You will ensure compliance with registration requirements, coordinate document translations, and support audits, inspections, and regulatory submissions across the product lifecycle.