Jun 16, 2022

Job Description

Registration Manager RCC-Europe

900 registrations we process on an annual basis to make sure our patients have access to their medications. To continue doing this we are looking for a talented Registration Manager in our office in Almere. The role is based in the Sandoz Regulatory Competence Centre - Europe (RCC-Europe), which is located on two sites in EU. The focus in our Almere office lies on all new submissions of the company for EU, Great Britain and Switzerland as defined in an agreed registration strategy, and makes sure the product is ready for launch from a regulatory perspective. The RCC-Europe team in the Netherlands exists of approx. 12 persons.

Within this dynamic team you will be amongst others responsible for the coordination of all activities, leading to the registration and maintenance of medicines at a national and EU level (MRP, DCP, CP), in such a manner that registration requests will be able to be lodged in accordance with project timelines, on time and complete. This is challenging and demanding job and therefore it is necessary you are able to focus on the registrations assigned to you.

Furthermore you will be:
• Looking after the registration of new products for the entire European market and/or for individual member states;
• Providing chemical-pharmaceutical, clinical and medical feedback and regulatory support to development sites and/or national organizations relating to the content of registration files;
• Compiling of the common product information texts in English
• Liaising and coordinating with registration authorities during the entire registration process, therefore you need excellent stakeholder management skills;
• Contributing to the compilation of working practices and training documentation.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• A University Degree in life sciences, medical or pharmaceutical;
• A minimum of three years’ experience in an (industrial) pharmaceutical environment;
• Experience within a generic pharmaceutical company is really advantageous;
• Communicative, proactive and detail oriented and in the possession of excellent stakeholder management skills.

Why consider Novartis?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!
If you have any questions regarding the recruitment process please contact: [email protected].
Product Dev SZ
Research & Development
Full Time
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Registration Manager RCC Europe

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