Introduction
A global pharmaceutical company specialized in the delivery of vaccines, medicines and animal health is looking for a regulatory submission planner to join their regulatory operations department in Brussels.
Organisation
Experis, part of the ManpowerGroup, is a global market leader in HR services and talent sourcing solutions.
Present in over 50 countries worldwide, our clients are amongst the most prestigious companies in today’s changing world of work. Experis-experts provide top candidates with challenging missions in the specialties IT, Engineering, Life Sciences , Finance and Human Resources. Your career is our mission !
Fonction
Responsibilities:
• You will be responsible for planning, coordinating and reviewing regulatory submissions (mainly variation applications) to European countries (EU, non EU countries, Switzerland)
• You will be responsible for obtaining supportive documentation for the regulatory submissions and for ensuring the assembly is performed by the publishing teams
• You will be responsible for the release to the Country Regulatory Affairs and for tracking the submission milestones of the assigned work
• You will take care of the maintenance of the regulatory submission planning and registration tracking databases to fulfill daily function and Records Retention tracking and management
• You will be in charge of the identification and gathering of local documents from country Regulatory Affairs team (mainly for MRP/DCP and NP products)
• You will develop the submission plan, ensure all components are obtained
• You will generate work order for dossier publishing teams
• You will review the submission before release
Prérequis
Qualifictions:
•3-5 years’ experience in the pharmaceutical regulatory affairs area
•Submission planning experience
•Excellent written and oral communication/interpersonal skills required
•Able to manage several submissions simultaneously and to multitask
•Enhanced skills for interacting and negotiating with others
•IT knowledge: working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum …)
•Ability to act upon assigned work responsible and to actively follow up on assignments.
•Able to collaborate effectively in a multi-cultural working environment
•Excellent English level (oral and written)
Offre
We offer a long term project with a permanent contract.
The possibility to grow in a supportive environment.
A salary in line with your experience and an attractive package of compensations and benefits.
Please get in touch or send your resume to
me************@st******.lu
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