Senior Principal - Regulatory Affairs

To see our ideas in action, or to join a new type of consulting firm, visit .\n\nAbout the Role\n\nInfosys Consulting is looking for talented and highly motivated consultants to join our Life Sciences consulting practice specializing in Regulatory Sub Practice of larger LifeSciences Consulting.\n\nResponsibilities\n\nIn depth knowledge of Pharma Regulatory Operations and Regulatory IT Systems aligned to core Functional and Technical competencies\nExpert in Regulatory area with ability to drive futuristic IT solutions and experience in client facing and agency thought leadership.\nUnderstanding and knowledge of processes related to health authority submissions, content authoring, labeling, lifecycle management of CMC, regulatory intelligence, and country-specific regulatory requirements – keenly aware of industry trends, needs and business requirements expected from clients\nAble to strategize and advise on the product roadmap and should work closely with the client in delivering solutions.\nAn empathic people manager responsible to mentor and guide a team for progressive outcomes\nLead strategic programs, manage program planning, execution and reporting; responsible for program resources, deliverables, quality, stakeholder communication, client buy-in, program risks, mitigations and budgets leading to successful program delivery.\nLead in sales pursuits in collaboration with larger Infosys teams; lead the proposal development process; proposal content creation and client presentations.\nDevelop solutions that enable adoption of digital capabilities for Life Sciences organizations. Participate in analyst meetings, industry speaking engagements, publish white papers/ viewpoints in leading industry journals.\nParticipate in practice development activities; coach junior consultants; participate in consultant training processes.\nAbility to travel 4 days a week to multiple client locations.\n\nWhat do we require?\n\nThe Candidate should have a rare blend of industry domain, process, technical and consulting skills. Consulting skills should entail client relationship management, effective executive communication, critical thinking in a consultative approach with our clients.

Additional skills that are highly desirable include value realization, process re-engineering, design thinking and agile delivery experienced\nShould have a master’s degree in a Life Science, Medical or Related discipline. Master's in business administration would be an added advantage.\nMinimum 15 years ’ experience in Regulatory Strategy, Operations and Intelligence across Biopharma and Medical Devices, with the majority in consulting roles at a Tier 1 IT company or Big 4 / management consulting firms\nDeep understanding of RIM systems i.e., Veeva Vault, LIQUENT and publishing tools.\nKnowledge of regulatory IT systems landscape and implementation experience inclusive of integration and Migration aspects\nForward thinking skills in reshaping patient support and market access agenda as it evolves.\nThought leadership and critical problem solving skills\n\nWhere are we hiring? Anywhere in India\n\nInfosys is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, spouse of protected veteran, or disability.