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

☞ ALSINOVA CRO

看过: 100

更新日: 30-11-2025

位置: Waterloo Walloon Brabant

类别: 市场/公关 列印

行业: Health Human Services

水平: Mid-Senior level

工作类型: Full-time

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工作内容

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

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

Our Benefits

Rejoindre Astek, c’est choisir :

  • un accélérateur d’expérience, où chaque mission est une opportunité de progresser
  • un accès à une multitude de projets techniquement passionnants pour nos clients comme en interne
  • un accompagnement de proximité individualisé pour un parcours professionnel sur mesure
  • un apprentissage continu, grâce à notre Académie de formation interne
  • un environnement de travail convivial et inclusif, soutenu par des pratiques RH certifiées #TopEmployer2025 Let’s move forward.
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最后期限: 14-01-2026

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