R&D Specialist (Formulation Development)

Client of Rawaj Company for Recruitment

The R&D Specialist is responsible for developing, optimizing, and supporting the formulation of pharmaceutical products, with a focus on compliance with international regulatory standards.

Key Accountabilities

• Develop and optimize formulations for controlled and injectable pharmaceutical products.
• Conduct laboratory-scale trials and evaluate critical quality attributes for parenteral dosage forms.
• Select and qualify excipients and raw materials based on compatibility, functionality, and regulatory compliance.
• Support reformulation and product improvement projects as needed.
• Design, execute, and analyze stability studies in accordance with ICH and SFDA guidelines.
• Support shelf-life determination and justification based on data analysis.
• Investigate and document formulation-related OOS, OOT, and deviation reports
• Support pilot, exhibit, and commercial-scale batch execution.
• Prepare comprehensive formulation development and technology transfer documentation.
• Provide technical support during process validation and commercial manufacturing phases.
• Prepare and review documentation for CTD/eCTD submissions (Modules 3.2.P.2 and 3.2.P.5).
• Ensure compliance with FDA, EMA, SFDA, and ICH guidelines throughout development.
• Support responses to regulatory queries and product registration activities.
• Work closely with Regulatory Affairs, QA, QC, and Manufacturing teams.
• Provide technical guidance during audits and regulatory inspections.
• Share technical expertise and provide training as required.