What we will accomplish together: Alsinova is looking on a regular basis for Technical Regulatory CMC Writers to join our consulting team for clients' projects (from big pharma to small biotech) based in Belgium. Your mission (should you decide to accept it): Your potential challenges will be various, depending on the clients' priorities. The list below gives you examples of our classic activities.

Your daily activities will be:

• The Technical Regulatory Writer is involved in the company’s regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions....
• Write CMC, “facility and equipment” parts and new files for WW regulatory File.
• Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion.
• Ensure the coordination with the departments involved in the writing/review process.
• Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities.
• Monitor that supportive data provided by other departments are compliant.
• Report significant issues.
• Manage the projects within all company/GRA tracking tools.
• Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.

You:

Our Benefits Joining Astek means choosing:

• an experience accelerator, where every assignment is an opportunity to progress
• access to a multitude of technically exciting projects for our clients as well as internally
• individualized, local support for a tailored career path
• continuous learning, thanks to our internal training academy
• a friendly and inclusive work environment, supported by #TopEmployer2025 certified HR practices Let's move forward.