Regulatory Operations Expert

You will be responsible for providing analytical support for developmental projects/comparative dissolution projects received from client sites. This includes being an interface with contract laboratories, suppliers, customers, and peers to define and improve project performance and expectations. You will coordinate with CRO to ensure that projects are completed within the timeline. Additionally, you will design scientific experiments, monitor lab work, and recommend further investigations based on experimental results. Your role will involve the preparation of test methods, technical documents, protocols, and reports when necessary. It is crucial to record information accurately, retain records and raw data properly, summarize, interpret, review data, and draw conclusions. You will analyze dissolution data sets, troubleshoot instrument or method-related problems, and adhere to GMP/safety requirements. Key interaction areas will include Drug Product development, Reg. CMC/LOC, and Spec management. Knowledge of invitro dissolution testing, comparative dissolution testing, statistical evaluation, and DoE is preferred. Familiarity with Regulatory Guidelines on dissolution studies such as FDA-SUPAC and ICH for validations and other emerging markets like China and Latin America is essential. Qualifications: - Masters in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD) as applicable - Proficiency in English and/or other languages as required Experience: - 10-12 years of experience in the analytical field is desirable - 7-9 years of relevant industrial experience in Analytical science/Formulation science/material management and overall drug development and manufacturing process - Strong verbal, written, and presentation skills - Leadership capabilities with attention to detail and multi-tasking skills - Ability to interact and influence with various stakeholders - Experience in coaching project team members - Strong attention to deadlines and budgetary guidelines - Knowledge of medical and drug terminologies, GxPs, and worldwide regulatory requirements - Familiarity with ICH guidelines Preferred Qualifications: - Masters in Pharmacy or related science degree with 7-9 years of experience in formulation or Analytical development - Knowledge of data management systems, pharmaceutical product life cycle, and Management Information System (MIS) - Experience in DoE and statistical expertise - Diploma or certification in Regulatory Affairs Work Environment: - Office based For more information on Equal Employment Opportunity (EEO) and Accommodations, please refer to our policies.,