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.Key ResponsibilitiesLead, 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.Core CompetenciesStrong results and process orientation for departmental achievement.Analytical mindset with a structured and responsible approach.Strong understanding and practice of cost consciousness.High attention to detail, accountability, and ownership.Excellent team-building, time management, and task management skills.Strong oral and written communication skills in English.Highly disciplined, motivated, and organized.Qualifications / Functional KnowledgeEducation: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 to read more about us and the journey of Julphar
