Regulatory Affairs Specialist | €50K - €80K | Home Office

Bedrijfsnaam: -
Plaatsingsdatum: 13/03/2019
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Brabant Netherlands.The CompanyJanssen develops treatments for some of the most devastating disorders and complex medical challenges of our times, including cancer, hepatitis, HIV/AIDS, diabetes, arthritis, dementia, and mental disorders. We focus our research on six strategic pathological areas: oncology, neurosciences, infectious diseases and vaccines, immunology, cardiovascular and metabolic disorders and pulmonary hypertension. They are wholly owned by Johnson & Johnson (J&J).

Role DescriptionThe Regulatory Management Center (RMC) is a new regional organization to handle the activities of local operating companies in EMEA, Asia Pacific and Latin America. At the RMC they handle tactical processes, regarding CMC Variations and Labeling Changes in the region.

The responsibility of RMC Submission Management is to lead wide range submission processes for multiple countries, preparing country-specific submission ready dossiers,manage Agency questions when required and ensure post-approval activities to take place for those submissions.

ResponsibilitiesYou will work on routine regulatory affairs maintenance activities (variations) for MRP and NP products, servicing mainly the North European countries (Baltics, Nordics, Benelux, UK, Ireland, Germany). You will be working independently in a virtual team where your colleagues will be in different locations. You will not be working strategically, but mainly be focussed on submission and implementation.

Requirements• A minimum of a University degree or equivalent by experience;
• At least 3 years of regulatory experience;
• In depth knowledge of local and regional regulations/legislation;
• Experience with RA tracking systems (e.g. TrackWise / SPS / MPD) is an asset.

Other informationThe position is located in the LOC of the respective region (EMEA, Asia Pacific, or Latin America). No relocation is required.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
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