About This Role
Working on registrations, product information, and artworks for current and future products is the core of this Regulatory Affairs Specialist role. You will ensure product compliance with registration requirements, combine attention to detail with strong planning skills, and collaborate with various internal and external stakeholders.
Responsibilities
- Maintain registration dossiers, prepare official product information, and coordinate translations of documents including Patient Information Leaflets, Summaries of Product Characteristics (SmPCs), and packaging texts
- Manage artworks for the product portfolio, coordinating changes from initiation through implementation and ensuring packaging materials comply with registered product information, applicable laws and regulations, and internal quality standards
- Respond to questions from local health authorities and support internal and external audits and inspections
- Contribute to the earliest possible approval of registration applications and support product launches and manufacturing site transfers
- Provide general and product-specific Regulatory Affairs support to internal and external stakeholders, including Business Units, Portfolio & Launch, Supply, manufacturing sites, international Artwork teams, Medical, and Quality
- Keep Regulatory Affairs databases up to date and ensure relevant GxP and RA documentation is archived in accordance with applicable requirements
- Support local RA projects and develop into a subject matter contact for specific RA processes, tools, or projects
- Ensure compliance with Sandoz standards, local procedures, applicable laws and regulations, and health authority requirements
- Work accurately, monitor relevant deadlines, and maintain professional communication with internal and external stakeholders
Requirements
- Detail-oriented and proactive, taking ownership of your work and comfortable working in a highly regulated environment
- Ability to work independently while recognizing when alignment with others is needed
- Bachelor
-s or Master
-s degree, preferably in biomedical sciences, pharmacy, pharmacology, or a 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 organizational 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, make informed decisions, and deliver high-quality results
- Ability to look beyond the immediate question or assignment, recognize connections, and maintain an overview of the bigger picture
