Regulatory Affairs Specialist: Dossier & Artwork Champion

Sandoz; Almere; On-site; EUR 60,000 - 90,000; Full time

Job summary

Sandoz is seeking a Regulatory Affairs Specialist in the Netherlands, based in Almere. You will ensure product registrations, official product information, and artwork alignment across the product portfolio, working with internal and external stakeholders to deliver compliant documentation.

You bring a degree in biomedical sciences or pharmacy, experience in pharma, and fluent Dutch and English. You’ll thrive in a highly regulated environment, manage priorities, and contribute to launches and

Qualifications

• Bachelor's or Master's in biomedical sciences, pharmacy, pharmacology or related field.
• Experience in the pharmaceutical industry, preferably in a highly regulated environment.
• Excellent command of Dutch and English, both written and spoken.
• Strong planning and organisational skills with attention to detail.
• Good written communication skills and experience with data management and IT systems, including Microsoft Office.
• Ability to set priorities independently and deliver high‑quality results.
• Ability to see connections and maintain an overview of the bigger picture.

Responsibilities

• Maintain registration dossiers, prepare official product information and coordinate translations of documents including Patient Information Leaflets and SmPCs.
• Coordinate artworks changes from initiation through implementation and ensure packaging texts comply with registered information and regulations.
• Respond to questions from local health authorities and support audits and inspections.
• Support early approval of registration applications and assist product launches and site transfers.
• Provide general Regulatory Affairs support to internal and external stakeholders, including Business Units and international teams.
• Keep Regulatory Affairs databases up to date and archive GxP and RA documentation.
• Develop into a subject matter contact for specific RA processes, tools or projects.

Skills

Detail oriented

Proactive

Planning

Organisational skills

Deadline management

Independent working

Strong communication

Education

Bachelor's or Master's in biomedical sciences/pharmacy/pharmacology or related field

Tools

Microsoft Office

Data management

Job description

Sandoz is seeking a Regulatory Affairs Specialist in the Netherlands, based in Almere. You will ensure product registrations, official product information, and artwork alignment across the product portfolio, working with internal and external stakeholders to deliver compliant documentation.

You bring a degree in biomedical sciences or pharmacy, experience in pharma, and fluent Dutch and English. You’ll thrive in a highly regulated environment, manage priorities, and contribute to launches and