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Regulatory Affairs Service Delivery Manager

Régió: Budapest

Randstad Hungary Kft.

Hozzáadva: 2017.04.26.
Jelentkezési határidő: 2015.05.06.
Hirdetés azonosító: 901241

Regulatory Affairs Service Delivery Manager

Our client is a leading provider of information technology, consulting ad business process outsourcing services. And we are looking for Regulatory Affairs Service Delivery Manager for coordinate medical registration.


-Strong regulatory expertise in handling of worldwide Regulatory procedures followed by US, Europe, Canada, LATAM, ASEAN and ROW
-Develop and mentor associates by providing expertise in CTD/eCTD/ACTD/NeeS Submission
-Coordinate in Developing and implement regulatory strategies for investigational, and commercial drug products
-Develop/adopt & implement best practices for producing & maintaining high quality deliverables
-Regulatory Dossier development & management across product life cycle including IND, NDA and post marketing phase
-Ensure high quality level liaison with Health Authorities (HAs) or support local/regional regulatory organizations for advisory meetings with agencies or any other technical contacts to defend submission strategy or challenge file evaluation outcomes for allocated projects /products.
-Design the relevant technology platform which sets new standards in the market place for Regulatory affairs
-Accountable to deliver high level quality registration documents according to client requirements and per project plan(s)
-Create and maintain regulatory affairs policies (SOPs/SWIs/SWPs), as applicable, for all aspects of Regulatory affairs


-Good knowledge of the global regulatory environment and different Regulatory bodies
-Ability to direct regulatory strategy and contribute to its outcome when necessary.
-Strong regulatory expertise in handling of worldwide Regulatory procedures followed by US, Europe, Canada, LATAM, ASEAN and ROW
-Extensive submissions experience in any format like CTD/eCTD/ACTD/ NeeS or ACTD as per country-specific requirements
-Excellent leadership and people management skills.
-Life sciences qualification (B.Pharm /M.Pharm or equivalent)

Amit kínálunk:

-Opportunity to be part of a rapidly expanding organization
-A role that provides you progress both professionally and personally
-Open and colourful work place with multicultural community
-Pleasant and inspiring working atmosphere and state-of-the-art technologies
-IT Academy courses, professional development and career path
-Convenient location and nice office building
-Competitive salary and cafeteria benefits

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