Technical Regulatory CMC Writer

About Alsinova

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

Your potential challenges will be various, depending on the clients’ priorities. The list below gives you examples of our classic activities.

Your Daily Activities

• 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 changecontrols impacting both CMC and facilities.

Qualifications

• 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.
• Proficiency with Microsoft Office, PowerPoint & Excel.
• French language skills.
• Good level of spoken and written English.
• Good communication skills.
• Strong writing skills.
• Analytical skills, creative and critical mind.
• Ensures coherence between contributions / quality of final results.
• Team player.

Our Benefits

• 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 Top Employer certified HR practices.