Job description
R&D Documentation Key Responsibilities: Prepare and review technical documentation including: Master Formula Records (MFR) Batch Manufacturing Records (BMR) Product Development Reports (PDR) Technology Transfer Dossiers Analytical Method Development & Validation Reports Stability protocols and reports Draft, revise, and maintain SOPs related to: R&D operations (Formulation & Analytical) Documentation practices Equipment handling and process controls MHRA-compliant procedures and documentation standards Ensure all documentation is MHRA-ready, audit-compliant, and follows data integrity (ALCOA+) principles.
Support preparation of CTD/eCTD regulatory modules, especially CMC (Module 3) sections, as per MHRA submission requirements. Liaise with cross-functional teams (F&D, ADL, QA, Regulatory, Manufacturing) for accurate documentation and technical data. Maintain document control systems, ensure version control, and manage archival of records.
Provide documentation support during MHRA audits, mock audits, and internal quality reviews. Track project documentation timelines and deliverables to ensure regulatory submission readiness. Review and maintain change control documentation linked to formulation and analytical processes.