Regulatory Submission Planner - Pharmaceuticals

Belgium  ‐ Onsite
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Description

Function: 

The Regulatory Submission Planner will work within the team in Brussels. The person will be responsible for the planning, the co-ordination and the delivery of electronic dossier for the regulatory filings, required to maintain the marketing authorization of the company medicinal products in Europe. 



Responsibilities: 

• Responsible for planning, coordinating and reviewing regulatory submissions (mainly variation applications) to European countries (EU, non EU countries, Switzerland) 

• Responsible for obtaining supportive documentation for the regulatory submissions and for ensuring the assembly is performed by the publishing teams 

• Responsible for the release to the Country Regulatory Affairs 

• Responsible for tracking the submission milestones of the assigned work 

• Responsible for maintaining the regulatory submission planning and registration tracking databases to fulfil daily function and Records Retention tracking and management 



Primary tasks: 

1. Identify and gather local documents from country Regulatory Affairs team (mainly for MRP/DCP and NP products) 

2. Develop the submission plan, ensure all components are obtained 

3. Generate work order for dossier publishing teams 

4. Review submission before release 



Educational Requirements: 

Bachelor's degree required with 4 years’ experience in regulatory environment 



Qualifications: 



• 3-5 years’ experience in the pharmaceutical regulatory affairs area 

• 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.
Start date
n.a
From
Quanta Consultancy Services
Published at
09.01.2016
Contact person:
Lee Mitchell
Project ID:
1048503
Contract type
Freelance
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