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Offre: Support RA activities 2058:Randstad

Job description:

Support RA activities 2058

12-9-2019 bruxelles

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description de l'entreprise

Their mission: To discover, develop and provide innovative products and services that save and improve lives around the world.

description de la fonction

Do you have at least 2 years practice in the pharmaceutical industry and expertise of EU regulatory procedures?
Don't hesitate to contact me: megane.libert@cx.ausy.be

Support RA activities in the EU region, the non-EU CES countries + Switzerland-close collaboration with the RA Liaison Primary activities include, but are not limited to: 
   »Providing strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements
   »Liaising with Regional Submission Planner to provide input and ensure alignment on submission plans. Collaborating closely with Regulatory Operations to establish submission timelines
   »Collaborating closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies
   »Preparing the English Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Worldwide Product Labelling
   » For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA
   »Ensuring updates to regulatory databases 
   »Keep up to date with EU procedural requirements and legislation

vos atouts
   » Degree in life sciences
   » Minimum of 2 years practice in the pharmaceutical industry
   » expertise of EU regulatory procedures and development of medicinal products in general is preferred
   » Good organizational expertise, proven capability to multi-task, excellent written and verbal communication expertise in English
   » Demonstrates the capability to review regulatory documents for accuracy
   » Understands the end-to-end pharmaceutical lifecycle

qu'offrons-nous?

We offer an attractive income with extra-legal advantages : 
   » Group insurance
   » Hospitalisation insurance
   » Meal vouchers of 7 euros gross per working day
   » Reimbursement km or company car 
   » Monthly allowance (50 euros net per month)
   » A 13th month
   » Training
   » Etc
A rate as freelance is also possible

sommaire

fonction
   . chef de projet / manager (m/f)

type de job
   . temps plein, freelance

type contrat
   . missions à long terme

référence
   . CXRSP-84910
informations de contact
Aurélia Sautière
02 474 60 16

 

informations de contact
Aurélia Sautière
02 474 60 16

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: bruxelles, Ander
Address: bruxelles
Company Type Employer
Post Date: 09/12/2019 / Viewed 24 times
Contact Information
Company: Randstad
Contact Email: megane.libert@cx.ausy.be


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