Senior Regulatory Leader (Life sciences domain)

India's marquee global technology & consulting company. They are an international flag-bearer of technical and managerial excellence. With offices around the globe, the company has a comprehensive presence across multiple segments of the technology product and service industries as well as a blue-chip roster of clients for their Consulting engagements. They are a respected career company and a long-term wealth creator.

The Job

We are seeking to identify senior leaders for the Life Sciences Consulting practice, with a focus on the Regulatory Sub-Practice. This role is ideal for individuals who are passionate about regulatory affairs in the life sciences industry and are eager to contribute to impactful client solutions

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

Your Profile

• 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
• Thought leadership and critical problem solving skills