Leverage your abilities and join a leading company specializing in medical device manufacturing in Saudi Arabia.
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 (FDA, EMA, SFDA, ICH). This role involves hands-on formulation work, stability and performance evaluation, scale-up and technology transfer, and collaboration with cross-functional teams to ensure successful product development and commercialization.
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.
Knowledge, Skills, and Experience
- Bachelor’s or Master’s Degree in Pharmacy or Pharmaceutical Sciences.
- Minimum 5 years of hands-on experience in pharmaceutical formulation development of Controlled Medicines and/or Injectables (Parenteral products).
- Hands-on experience in sterile dosage forms, formulation optimization, and stability testing.
- Strong understanding of global regulatory standards (FDA, EMA, ICH, SFDA).
- Excellent analytical, documentation, and communication skills.
