Job Overview Responsible to provide analytical support for the developmental projects comparative dissolution projects received from other client sites Summary of Responsibilities These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities skills and duties as individual contributor globally Responsible to provide analytical support for the developmental projects comparative dissolution projects received from other client sites Responsible to be an interface with contract laboratories suppliers customers and peers to define and improve project performance and expectations Responsible for to coordinate with CRO and ensure that project complete with in timeline Designs scientific experiments Actively and personally monitor lab work Recommends expansion or curtailment of investigations on the basis of experimental results or scientific information Responsible for the preparation of test methods technical documents protocols and reports whenever required Is responsible for the proper recording of information Ensures that records and raw data are properly retained Summarizes interprets reviews data and draws conclusions Analyzing and drawing interpretation out of the dissolution data sets Trouble shooting the problems associated with instruments or method Performing activities following the GMP safety requirements related to the assigned activity Knowledge of In vitro dissolution testing Comparative dissolution testing including multimedia dissolution Interface with Contract labs Dissolution Investigations Basic knowledge on formulation Oral solid dosage forms Qualifications Minimum Required Bachelor s in Pharmacy or related science degree or equivalent advanced degree e g PhD or Masters as applicable Fortrea may consider relevant and equivalent experience in lieu of educational requirements Speaking-English at ILR level 3 or higher Writing Reading- English at ILR level 4 or higher Leadership problem solving interpersonal skills Experience Minimum Required At least 4-6 years of experience in Regulatory Affairs Quality Assurance Analytical science Formulation science material management and overall drug development and manufacturing process Excellent command of written and spoken English Technical proficiency with Microsoft Office suite of applications Document Management and publishing tools Good understanding of the pharmaceutical product life cycle Valuable organizational and time management ability Excellent interpersonal skills Good analytical capabilities and Customer focus Good review skills and concern for quality Scientific or Clinical research experience desirable Capabilities to face internal and external Audit situation Good understanding of regulatory requirements GxP and ICH guidelines Experience in regulatory document formatting and ensuring publishing readiness of documents regulatory affairs regulatory operations regulatory publishing Preferred Qualifications Include Bachelor s in Pharmacy or related science degree or equivalent advanced degree e g PhD or Masters with at least 4-6 years of relevant experience Analytical science Formulation science material management and overall drug development and manufacturing process Knowledge of data management system pharmaceutical product life cycle Diploma or certification in Regulatory Affairs Leadership problem solving interpersonal skills Work Environment Work environment Office workplace Learn more about our EEO Accommodations request here

📌 Regulatory Operations Specialist Ii (Maharashtra)
🏢 Fortrea
📍 Maharashtra