Senior Regulatory Leader (Life sciences domain) EDGE Executive Search

15.0 - 24.0 years

40 - 70 Lacs

Pune, Gurugram, Bengaluru

Hybrid

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 . 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

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