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Sr. Principal Consultant, Regulatory Strategy and Advisory

2 months, 3 weeks ago
Germany
Full-time
Lead
Consultant
Operations
Agile
Apply Now
Infosys

Infosys

Infosys specializes in providing comprehensive consulting and IT services that facilitate digital transformation for clients across various industries, leveraging advanced technologies and innovative solutions to enhance business processes and drive me...

Internet Software & Services
100K+
Founded 1981
View All Jobs 50

Description

  • Work with global business regulatory experts and IT experts to analyze, develop, and implement regulatory processes and solutions.
  • Design innovative product features for health authority submission management, content authoring, labeling, regulatory intelligence, and country-specific regulatory requirements.
  • Formulate recommendations to improve business processes and system configuration and develop user requirements for key use cases.
  • Coordinate implementation activities across solution design, configuration, systems integration, data migration, validation, and training.
  • Serve as the primary customer liaison and manage communication between the project team, customer, internal stakeholders, and vendors.
  • Advise on product roadmap direction and collaborate closely with clients to deliver solutions.
  • Mentor and guide a team to support progressive outcomes.
  • Support business in implementing innovative regulatory platform solutions using agile ways of working.

Requirements

  • Master’s degree in a life science, medical, or related discipline; MBA is an added advantage.
  • 12-15 years of experience in drug development, regulatory, clinical operations, or medical devices.
  • Deep understanding of regulatory information management systems such as Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Extedo eCTD Manager, and Trackwise.
  • Knowledge of the regulatory IT systems landscape, including implementation, integration, and migration experience.
  • In-depth knowledge of pharma regulatory operations and regulatory IT systems aligned to functional and technical competencies.
  • Expertise in regulatory and clinical areas with client-facing and thought leadership experience.
  • Understanding of health authority submissions, content authoring, labeling, lifecycle management of CMC, regulatory intelligence, and country-specific regulatory requirements.
  • Strong consulting skills including client relationship management, executive communication, critical thinking, process re-engineering, design thinking, and agile delivery experience.
  • Smart, self-driven, high-energy, and intellectually curious with top-notch communication skills.

Interested in this position?

Apply directly on the company website

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