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Submission Development Lead

SEC Recruitment Ltd

Part time |  Contract  |  Fresher  |  Salary type not mentioned Salary not mentioned  |  1 Jobs  | English

Job Description

Submission Development Lead
Based in Belgium, in the area of Brussels
Salary depending on experience
6 months to a year Contract

My client, one of the world's largest pharmaceutical companies, is now seeking a Submission Development Lead to join in with their on-going success, in their office in Brussels.

Job Summary:

As a Regulatory Submission Planner, you'll work with the Regulatory Operations team in Belgium.
You'll be responsible for the planning, the coordination and the delivery of eCTD for the regulatory filings required to maintain the marketing authorization of the company medicinal products in Europe.

Accountabilities/Responsibilities:

-Planning, coordinating and reviewing regulatory submissions (mainly variation applications) to European countries (EU, non EU countries, Switzerland)
-Obtaining supportive documentation for the regulatory submissions and for ensuring the assembly is performed by the publishing teams
-Reviewing submission before release
-Releasing to the Country Regulatory Affairs
-Tracking the submission milestones of the assigned work
-Maintaining the regulatory submission planning and registration tracking databases to fulfil daily function and Records Retention tracking and management

Essential Skills & Capabilities:

Educated to a minimum of Bachelor's degree in the life science you will have:

-Ideally 4 years of experience in the pharmaceutical regulatory affairs area
-Experience with MRP, DCP, and NP products
-Excellent written and oral communication skills in English
-Working knowledge of the standard computer applications (MS Office applications, Adobe Acrobat, MS Project, Documentum )
-The ability of multitasking and collaborating effectively in a multi-cultural working environment
-Proven experience of negociating with others
-Ability to multitask

If it sounds like you, if you want additional information about the role, please contact me or email your CV to (see below)

We try our best to respond to every application and you can be sure every single one will be reviewed, however due to the potential high volume of responses should you not hear back within 10 days from your application assume you have not been successful on this occasion.

Audrey Petitier
(see below)

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