R&D Specialist (Formulation Development) - (Controlled Medicines & Injectables) | Saudi Arabia

RAWAJ; Riyadh; On-site; SAR 50,000 - 70,000; Full time

Job summary

A leading company specializing in medical device manufacturing in Saudi Arabia is seeking an R&D Specialist. The role involves developing and optimizing formulations for pharmaceutical products, ensuring compliance with FDA, EMA, SFDA, and ICH guidelines. Ideal candidates will have at least 5 years of experience in pharmaceutical formulation development, particularly for Controlled Medicines and Injectables. Responsibilities include conducting trials, stability testing, and collaborating with cross-functional teams to support successful product development and commercialization.

Qualifications

• Minimum 5 years of hands-on experience in pharmaceutical formulation development of Controlled Medicines and/or Injectables.
• Experience in sterile dosage forms and formulation optimization.
• Strong understanding of global regulatory standards including FDA, EMA, SFDA, and ICH.

Responsibilities

• Develop and optimize formulations for controlled and injectable pharmaceutical products.
• Conduct laboratory-scale trials and evaluate critical quality attributes for parenteral dosage forms.
• Prepare comprehensive formulation development and technology transfer documentation.

Skills

Pharmaceutical formulation development

Regulatory compliance

Analytical skills

Communication skills

Education

Bachelor’s or Master’s Degree in Pharmacy or Pharmaceutical Sciences

Tools

Stability testing equipment

Job description

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.