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Regulatory Affairs Associate

2019-03-12 CLS Services | Breda | WO / MBA | Fulltime | Sluit 2019-05-11

Do you like to work in a virtual global team on regulatory submission processes for multiple countries? Then we are looking for you! The responsibility of the Submission Management Unit is to lead a wide range of submission processes for multiple countries, preparing country-specific ...

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Cilag B.V., we are searching for a Regulatory Affairs Associate.

Company profile
Janssen-Cilag companies operate in virtually all countries of the world and are active in a number of therapeutic areas such as pain, psychiatry, neurology, gastrointestinal and fungal diseases. Over 6,000 Janssen-Cilag employees throughout Europe develop and market innovative, high-quality medicines. The site in Breda incorporates around 250 employees. Janssen-Cilag is a product of the merger of two companies, Janssen Pharmaceutica and Cilag. In the Netherlands they are active since 1969.

The products of Janssen-Cilag are divided in several business units. All these units are supported by Human Capital, E-business en Integrated Customer Management, Finance & Logistics, Medical Department en Corporate Affairs. The clinical R&D department is part of the international organisation of Janssen-Cilag.

Department
The Regulatory Management Center is a new regional organisation to handle the majority of LOC activities led by senior regional regulatory staff, where they will handle tactical LCM processes (CMC Variations and Labelling Changes) in the region. The Center will be embedded in the AP, EMEA and LA regional organisations, and it will work in close collaboration with the respective LOCs and regional and global departments.
The RMC is a virtual, dedicated team consisting of GRA regional team members (direct reports) and LOC team members (matrix organisation).


Job description
Do you like to work in a virtual global team on regulatory submission processes for multiple countries? Then we are looking for you!

The responsibility of the Submission Management Unit is to lead a wide range of 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.
You will be working on routine regulatory affairs (RA) maintenance activities (variations) for MRP and NP products, servicing mainly the North European countries (Baltics, Nordics, Benelux, UK, Ireland, Germany). This role is operationally focussed, meaning you will not be working strategically on the dossiers but will mainly be involved in submission and implementation activities.

Who we're looking for
The ideal candidate has a MSc with at least 3 years of regulatory experience in a local operating company. You have in depth knowledge of local and regional regulations/legislation and, preferably, experience with using RA tracking systems (TrackWise / SPS/MPD). As this is a virtual team and colleagues are located in different locations, we are looking for someone who is independent, preferably has experience in (one of) mentioned countries, is cultural sensitive with excellent communication skills and with a lot of initiative. Experience with working in a virtual team and/or global organisation is advantageous.
Are you the pro-active team player we are looking for?

Additional vacancy information
Reference: A1900037
Contract: Temporary contract with CLS Services
Education: WO/MSc.
Terms: Project for 9 months. Must be able to work flexible hours to accommodate early morning/evening meetings/ teleconferences with different time zones
Occasional international travel (3-5x/year) may be required.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555



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