Registration Manager Rer
1 week geleden
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.
**Your Key Responsibilities**:
**Your responsibilities include, but not limited to**:
- 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.
**What you’ll bring to the role**:
**Essential 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.
**You’ll receive**:
We offer temporary employment for 1 year with probation period with flexible working, learning and development opportunities.
**Why Sandoz?**
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
The future is ours to shape
**Commitment to Diversity & Inclusion**:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
**#Sandoz**
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