Job Description

As a Business Consultant and Subject Matter Expert, You will be the driving the interactions with clients for understanding business problem, guiding and defining solutions along with the definition of business scope and requirements with respect to Pharmaceutical Regulatory Affairs. You would be having hands on experience working in regulatory area with an excellent exposure by either being part of a pharmaceutical organization or a software service provider or a software product and solutions provider who specializes in this area. This demands expert knowledge of Pharmaceutical Regulatory Affairs domain and associated process. Good knowledge of Regulatory Information Systems (RIMS). Regulatory Affairs landscape of Pharmaceutical R&D operations. The role also demands an expert knowledge on existing and upcoming local and global regulatory requirements and guidance and ability to bring out a point of view how those could be addressed by the pharmaceutical organizations. The role demands ability to strategizing and bring next generation solution perspectives to the clients and also the ability to network and connect with key business stakeholders to enhance Infosys value proposition and business. A day in the life of an Infoscion As part of the Infosys consulting team, your primary role would be to get to the heart of customer issues, diagnose problem areas, design innovative solutions and facilitate deployment resulting in client delight. You will develop a proposal by owning parts of the proposal document and by giving inputs in solution design based on areas of expertise. You will plan the activities of configuration, configure the product as per the design, conduct conference room pilots and will assist in resolving any queries related to requirements and solution design You will conduct solution/product demonstrations, POC/Proof of Technology workshops and prepare effort estimates which suit the customer budgetary requirements and are in line with organization s financial guidelines Actively lead small projects and contribute to unit-level and organizational initiatives with an objective of providing high quality value adding solutions to customers. If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Primary skills:Life Sciences - Regulatory Systems Ability to develop value-creating strategies and models that enable clients to innovate, drive growth and increase their business profitability Good knowledge on software configuration management systems Awareness of latest technologies and Industry trends PhD /Masters/ Bachelor s Degree in Life sciences/Pharmaceutical Sciences from recognized universities or equivalent foreign degrees. Expert in Pharmaceutical Regulatory Information Management landscape and systems in a pharmaceutical organization Excellent knowledge in Regulatory Affairs Operation in global Pharmaceutical landscape Good knowledge of business processes in EVMPD/IDMP /Product License Tracking (small molecules/Med devices/biologics)/CMC Strong business consulting skills associated with engagement spanning over 6-18 months. Experience in SME and Consulting assignments in Regulatory area Strong communication, Planning and Co-ordination skills and Stakeholder management Good Knowledge of SDLC processes and must have performed requirement analysis, use case modeling, etc. from a business analysis/consulting standpoint. Hands on experience in creating managing SDLC process documentation and artifacts Knowledge of vendors, products and solutions available in this area and expertise in some key products and solution Logical thinking and problem solving skills along with an ability to collaborate Understanding of the financial processes for various types of projects and the various pricing models available Ability to assess the current processes, identify improvement areas and suggest the technology solutions One or two industry domain knowledge Client Interfacing skills Project and Team management,

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Recruiter details

• Company Name: Infosys Limited
• Company Description: Infosys is a global leader in next-generation digital services and consulting. We enable clients in 45 countries to navigate their digital transformation. With over three decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change. We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.