R&D Specialist; Formulation Development Controlled Medicines & Injectables

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.

• 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.

• 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.