Regulatory affairs Specialist

  • Location: Brussels
  • Type: Contracting
  • Job #17191

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

The contractors will be Brussels based. Remote work is possible, but at least 1 day/week in the office is required. During the training it is advised to be present more often.
Assignment is for 6 months.

Support RA activities in the EU, UK, Switzerland and the non-EU Balkan countries for products approved through the centralized and decentralized/MRP procedures – in collaboration with the Regulatory Liaison.
Primary activities include, but are not limited to:
• Provides administrative regulatory support during filing and review of new submissions, variations, in order to safeguard submissions according to EU requirements.
• Plans and coordinates new submissions, variations, CHMP referrals, FUM. to ensure timely submission.
• Drafts of module 1 components and organizing the gathering of the module 1 components.
• Collaborates closely with Regulatory Operations to establish submission timelines and content of Module 1.
• Collaborates closely with Country RA Registration Managers in order to ensure timely submission.
• For the centralized procedure, supervises and coordinates the translation process to ensure timely submission to EMA.
• Provides other administrative support related to Marketing Authorization Applications to the Executive Director, Distinguished Scientist, Senior Principal Scientist, Associate Principal Scientist or Senior Scientist as needed.
• Ensures updates to regulatory databases.

Specific requirements (skills) or experience for the assignment?
• University degree (or similar such as A1 in Belgium), preferably in a science related to medicine, and at least four years of experience in the pharmaceutical industry with knowledge of the drug development and/or approval process.
• Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
• Can work across boundaries, demonstrates the ability to act as intermediary across boundaries.
• Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation.
• Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks.
• Demonstrates the ability to check regulatory documents to determine accuracy and find potential errors.

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Are you interested? Apply now with your cv! or email [email protected]

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