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.
As Technical Regulatory Writer, your responsibilities will be:
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 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.
Knowledge of regulatory procedures / systems / guidances
Knowledge of biologic process and process equipment.
Knowledge of Qualification / Validation principles.
Manages own time to meet agreed short-term targets
Good communication skills
Very good writing skills
Analytical skills, creative and critical mind
Ensures the coherence between contributions / quality of final results
Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
Experience working in validation/QA/production in Biologics/Pharmaceuticals industry
University level (Life Sciences background)
Microsoft, PowerPoint, Excel
Excellent command of English, Good command of French (German, Italian are a plus)