At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.
Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.
The Team Leader – New Product Development & Submission will lead and guide the R&D team in developing new pharmaceutical products across multiple dosage forms. This includes solids, liquids, semi-solids, injectables, inhalers, and biosimilars. The role involves project planning, process optimization, regulatory submissions, and technology transfer while ensuring adherence to cGMP/GDP principles.

EDUCATION:

• Master’s degree in Pharmacy (preferred) or Bachelor’s degree in Pharmacy.

EXPERIENCE:

• Extensive experience (10+ years) in formulation development of pharmaceutical dosage forms for global markets.
• Expert in QbD – Design Expert software application.
• Expert in Minitab software application.
• Significant exposure in addressing regulatory queries for US-FDA, EU, Canada, UAE, MENA, and KSA markets.
• Proven experience handling diverse dosage forms, including injectables, in an R&D environment.
  We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar

• Lead, guide, and plan the work of new and existing team members.
• Conduct literature surveys, patent searches, and prepare Prototype Formulation Reports.
• Identify the reference product and initiate procurement processes.
• Develop the Quality Target Product Profile (QTPP) based on literature review and reference product characterization.
• Identify and finalize API and excipient sources for new product development.
• Perform and conclude pre-formulation/drug-excipient compatibility studies for assigned projects.
• Participate in product process optimization, reformulation, and project closure, including report writing.
• Prepare registration dossiers of products for submission to health authorities.
• Plan, design, and perform pharmaceutical experiments using the QbD (Quality by Design) approach.
• Review analytical development data and systematically compile product information.
• Support manufacturing of batches for process optimization, submission, and bioequivalence (BE) studies.
• Knowledge and application of Bioequivalence, Q1/Q2/Q3, IVRT, and IVPT studies.
• Support manufacturing of pilot/scale-up batches with required documentation and execute technology transfer to production.
• Prepare and maintain R&D SOPs in compliance with cGMP and GDP principles.
• Prepare periodic project reports and submit updates to the Manager.
• Collaborate effectively with Analytical R&D, Supply Chain, Production, Quality Control, Quality Assurance, Regulatory Affairs, and Medical Affairs teams to ensure timely project completion.
• Handle eQMS activities related to projects.