All candidates should have a passion for helping our clients navigate transformational change; We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity.
The Candidate should have a rare blend of industry domain, process, technical and consulting skills. Industry domain expertise can be in one or more areas of Life sciences. 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
Role Summary, Core Expectations
- In depth knowledge of Pharma Regulatory Operations and Regulatory IT Systems aligned to core Functional and Technical competencies
- Expert in Regulatory and Clinical 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
Technical Credentials:
- Should have master’s degree in a Life Science, Medical or Related discipline. Master’s in Business Administration would be an added advantage.
- Minimum 12-15 years’ experience in Drug development, Regulatory, Clinical Operation and Medical Devices.
- Deep understanding of RIM systems i.e., Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc / FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise, or other regulatory information management systems Submission and publishing tools.
- Knowledge of regulatory IT systems landscape and implementation experience inclusive of integration and Migration aspects
Responsibility of / Expectations from the Role:
- Work with Business Regulatory experts and IT Experts globally to analyze, develop, and implement Regulatory processes and provide solutions to business problems and support business in implementing innovative Regulatory Platform solutions, in the most agile ways of working.
- Design innovative product features based upon industry requirements for Health Authority submission management, content authoring, labeling, regulatory intelligence, country-specific regulatory requirements, and emerging standards.
- Formulate recommendations for improvement in business processes and system configuration, developing user requirements to facilitate solutions to achieve the business vision and address key use cases.
- Coordinate with the implementation team across multiple phases and workstreams (e.g., solution design and configuration, systems integration, data migration, validation, and training).
- Primary customer liaison managing communication between the project team, customer, and internal stakeholders and vendors.
