Company: SEC Recruitment
Closing Date: 19 Dec 16
Salary (£): 60,000 - 80,000
Regulatory Submission Planner (Submission Development Lead)Brussels, BelgiumWe have a unique, varied and highly challenging opportunity available to work as a Submission Development Lead for a leading, global pharmaceutical company in Brussels, Belgium on an initial 12 month contract basis, with excellent potential for future extensions. ...
Regulatory Submission Planner (Submission Development Lead)
We have a unique, varied and highly challenging opportunity available to work as a Submission Development Lead for a leading, global pharmaceutical company in Brussels, Belgium on an initial 12 month contract basis, with excellent potential for future extensions.
Role and responsibilities:
• The overall purpose of the role will be to plan, coordinate and deliver electronic dossiers for the regulatory filings required to maintain the marketing authorisation of the company’s European medicinal products.
• The primary tasks will include identifying and gathering local documents, developing the submission plan, generating work orders for the publishing teams and reviewing submissions prior to release.
• You will be responsible for the planning, coordination and reviewing of regulatory submissions (mainly variation applications) to European countries (EU, non EU countries, Switzerland)
• You will obtain supportive documentation for the regulatory submissions and ensure the assembly is performed by the publishing teams
• Tale responsibility for the release to the Country Regulatory Affairs
• Tracking the submission milestones of the assigned work and maintaining the regulatory submission planning and registration tracking databases
Requires skills and qualifications:
• Good experience in the pharmaceutical regulatory affairs area
• Excellent written and oral communication skills are required
• Must be able to manage several submissions (typically 3-5) simultaneously and to multitask
• Strong interaction and negotiation skills
• IT knowledge: working knowledge of the standard computer applications – preferably will have good skills/knowledge of MS Office, Adobe Acrobat, MS Project and Documentum)
• Demonstrable proactive approach to work
• Able to collaborate effectively in a multi-cultural working environment
• Must be able to speak and write English fluently (no other language skills are required)
This is a fantastic opportunity to work for a leading, global pharmaceutical company in a varied, dynamic and challenging position, which is critical to the business.. There’s a very good chance that this position will offer you longevity on a contract basis should you wish.
To apply for this position and put yourself under immediate consideration, send your CV to email@example.com or call +44 (0) 207 255 6600
3rd Floor, 13-15 Moorgate London.
|Tel:||00 44 (0) 207 255 6600|
|Fax:||00 44 (0) 1483 888997|
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