Technical Regulatory CMC Writer – Waterloo, Belgium (F/M)

Alsinova; Waterloo; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Career progression

Challenging projects

Tailored career path

Continuous learning

Inclusive environment

Résumé du poste

Alsinova is seeking a Technical Regulatory CMC Writer based in Belgium to join our consulting team for pharma and biotech clients. You will handle technical writing for facilities and equipment across global regulatory files, coordinating with SMEs and QA teams to ensure timely submissions.

Requires 3+ years in CMC writing, knowledge of regulatory guidelines, and strong English/French communication skills. This role emphasizes cross-functional collaboration, data integrity, and rigorous review

Qualifications

• University level (Life Sciences background preferred) or equivalent by experience.
• At least 3 years of experience in writing CMC (technical) parts of regulatory documents.
• Experience working in validation/QA/production in Biologics/Pharmaceuticals industry.
• Knowledge of regulatory procedures / systems / guidance.
• Knowledge of biologic process and process equipment.
• Knowledge of Qualification / Validation principles.
• Manages own time to meet agreed short-term targets.
• Microsoft Office, PowerPoint & Excel proficiency.

Responsabilités

• 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.

Connaissances

Good communication skills

Writing skills

Analytical thinking

Team player

Microsoft Office

PowerPoint

Excel

Formation

Life Sciences degree

Outils

Microsoft Office

PowerPoint

Excel

Description du poste

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) thewriting/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 changecontrols impacting both CMC and facilities.

• Good communication skills.
• Writing skills.
• Analytical skills, creative and critical mind.
• Ensures the coherence between contributions / quality of final results.
• Team player.

You:

• University level (Life Sciences background is preferred) or equivalent by experience.

• At least 3 years of experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
• Experience working in validation/QA/production in Biologics/Pharmaceuticals industry.
• Knowledge of regulatory procedures / systems / guidance.
• Knowledge of biologic process and process equipment.
• Knowledge of Qualification / Validation principles.
• Manages own time to meet agreed short-term targets.
• Microsoft.
• PowerPoint & Excel.

• French.
• Good level of spoken and written English.

• Good communication skills.
• Writing skills.
• Analytical skills, creative and critical mind.
• Ensures the coherence between contributions / quality of final results.
• Team player.

Alsinova – An Astek Company

Alsinova is setting new standards for CROs by integrating multidisciplinary expertise with advanced technology. Alsinova offers a complete CRO solution, providing innovative, customised solutions in various life science segments: pharmaceuticals, biotechnology, medical devices, cosmetics, agri-food, veterinary and healthcare institutions.

Alsinova is the subsidiary of the Astek Group, a global player in engineering and technology consulting. Since its creation, the Group has based its development on a strong culture of entrepreneurship and innovation, and on the support and skills development of its 10 000 employees who are committed every day to promoting combination of digital technologies and complex systems engineering.

Join a Group rapidly developing in France and around the world, with a turnover of 730 M€ in 2025.

More on the Group on our websites https://alsinova.com and https://astek.net.

Astek is committed to the employment of people with disabilities.

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 #TopEmployer2026 certified HR practices

Let’s move forward.