About Us:

Infosys Consulting is a global management consulting firm helping some of the world's most recognizable brands transform and innovate. Our consultants are industry experts that lead complex change agendas driven by disruptive technology. With offices in 20 countries and backed by the power of the global Infosys brand, our teams help the C-suite navigate today's digital landscape to win market share and create shareholder value for lasting competitive advantage. To see our ideas in action, or to join a new type of consulting firm, visit us at www.InfosysConsultingInsights.com.

Responsibilities:

- In depth knowledge of Pharma Regulatory Operations and Regulatory IT Systems aligned to core Functional and Technical competencies

- Expert in Regulatory area with ability to drive futuristic IT solutions and experience in client facing and agency thought leadership.

- Understanding 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

- Able to strategize and advise on the product roadmap and should work closely with the client in delivering solutions.

- An empathic people manager responsible to mentor and guide a team for progressive outcomes

- Lead 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.

- Lead in sales pursuits in collaboration with larger Infosys teams; lead the proposal development process; proposal content creation and client presentations.

- Develop 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.

- Participate in practice development activities; coach junior consultants; participate in consultant training processes.

- Ability to travel 4 days a week to multiple client locations.

Basic Qualifications:

- The 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

- Should have master's degree in a Life Science, Medical or Related discipline. Masters in business administration would be an added advantage.

- Minimum 15 years' experience in Regulatory Strategy, Operations and Intelligence across Biopharma and Medical Devices.

- Deep understanding of RIM systems i.e., Veeva Vault, LIQUENT and publishing tools.

- Knowledge of regulatory IT systems landscape and implementation experience inclusive of integration and Migration aspects

- Forward thinking skills in reshaping patient support and market access agenda as it evolves.

- Thought leadership and critical problem-solving skills