**Job Title:** Senior Executive/Executive FRD Non Orals **Business Unit:** R&D1 Regulatory Affairs **Job Grade** G11B/G12A **Location :** Baroda At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each others journeys. **Job Description** + To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form (Implant, In-situ-gel, etc.) based on QbD approach. + To execute the experiments as per Design of experiments + To do literature search, prepare summary report and review for ANDA projects. + To prepare product development study protocols and reports as per regulatory requirements. + To enter the experimental details, observations and test request in the eLNB/METIS software. + Experimental trials and stability study results compilation and interpretation using MINITAB software. + To prepare Technology Transfer documents like MF, Risk Assessment based upon CPP & CQA, + To prepare justification for import material, documents for form 29 application and Common Pharmaceutical Document for DCGI submission. + To execute scale up / exhibit batches at plant and prepare scale up summary report + To prepare Stability protocol as per regulatory requirement. + To prepare Product Development Report, Risk assessment report for Elemental impurities, Residual solvents and Extractable for regulatory submission. + To prepare pre-ANDA meeting package, scientific justification and /or report for various regulatory agency + To prepare SOPs related to laboratory equipment / instrument. + To be a part of Equipment / Instrument Qualification activity in case of procurement of any new Equipment / Instrument and prepare and review qualification documents. + To comply with the internal quality system while performing any activity. + To co-ordinate with cross functional departments like ADD, RA, CQA, Plant for project / product related activity. **Travel Estimate** NA **Job Requirements** **Educational Qualification** M. Pharm **Experience** _Tenure_ : 3-6 years **Your Success Matters to Us** At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.