Senior Principal - Regulatory Affairs

Location: Bengaluru

About the Company

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

About the Role

Infosys Consulting is looking for talented and highly motivated consultants to join our Life Sciences consulting practice specializing in Regulatory Sub Practice of larger Life Sciences Consulting.

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.

What do we require?

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 a master’s degree in a Life Science, Medical or Related discipline. Master's in business administration would be an added advantage.
Minimum  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
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

Where are we hiring?  Anywhere in India

Infosys 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.