Associate Regulatory Site Officer

Science Talents is part of House of Talents, an international HR services group specialized in bottleneck professions. You will be working in a no-nonsense environment where team spirit, drive and eagerness to learn are key.

We are very open and communicative go-getters who are keen on results and quality.

To further strengthen our growth, we are constantly looking for new colleagues within Project Staffing.

Working as a consultant equals working with a fixed contract at Science Talents. You get the chance to work on different projects in your field of expertise and gain new experiences in life sciences, the chemical sector, and the food industry. 

Work is important; however, we also attach great value to a healthy dose of fun@work! Triggered? Let's meet!

• Managing and reviewing of CMC (Chemistry, Manufacturing and Controls) dossiers, variations, renewals, annual reports, site registrations and territory extensions as part of regulatory product lifecycle management responsibility
• mplementing change control updates from our partnered sites into the existing regulatory dossiers and prepare associated regulatory CMC documentation for submission to the authorities, in collaboration with Sanofi experts and external partners
• Analyzing impact of proposed change controls on the existing regulatory submissions
• Review operational documentation/reports in order to ensure compliance with the dossiers

• Bachelor or master with scientific background
• CMC background/experience required
• Regulatory background/experience required + experience with major market submissions such as US, EU, Japan, China,…
• Regulatory database (Veeva Vault RIM) experience required
• Previous experience with working at Sanofi is considered highly beneficial
• Good organizational skills
• Attention to details
• Good communicator and project manager
• Proven ability to work across functions and cultures

Will you become one of us? Join a financially sound company and become part of a group of no fewer than 2,500 top colleagues! We cannot wait to meet you! Fill in the form below and we will reach out to you soon.

contract of indefenite duration, included:

* company car + fuel card

* Health insurance

* Meal vouchers of 8€ per day worked

* Net allowances

* Group insurance

* Smartphone subscription

* end of year bonus (13th month)

* Eco vouchers