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

Astek Middle East; Waterloo; On-site; CAD 70,000 - 90,000; Full time

Job summary

Astek Middle East is seeking a Technical Regulatory CMC Writer based in Waterloo, Canada. The role involves regulatory writing and project management for clients in the pharmaceutical and biotech sectors. Ideal candidates will have a Life Sciences background and substantial experience in technical writing for regulatory documents, ensuring compliance and timely submissions. Join a team committed to high standards and ongoing professional development while working on diverse projects within a supportive environment.

Benefits

Continuous learning through training academy

Friendly and inclusive work environment

Individualized local support for career path

Qualifications

• At least 3 years of experience in writing CMC parts of regulatory documents.
• Experience in validation/QA/production in Biologics/Pharmaceuticals industry.
• Knowledge of regulatory procedures/systems/guidance.

Responsibilities

• Involved in regulatory activities related to new & existing products.
• Write CMC parts and manage writing/review processes.
• Coordinate with departments involved in writing/review.

Skills

Writing skills

Analytical skills

Good communication skills

Team player

Education

University level (Life Sciences background preferred)

Tools

Microsoft Office

Job description

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

Join to apply for the Technical Regulatory CMC Writer – Waterloo, Belgium (F/M) role at Astek Middle East

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

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Join to apply for the Technical Regulatory CMC Writer – Waterloo, Belgium (F/M) role at Astek Middle East

What We Will Accomplish Together

Alsinova is looking on

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.

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.
• 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

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 705 M€ in 2024.

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

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Marketing, Public Relations, and Writing/Editing

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