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.