Regulatory Systems Manager

5 days ago

Mumbai, Maharashtra, India beBeeInformation Full time US$ 94,200 - US$ 1,43,683
Job Description

As a senior manager of regulatory information management systems, you will be responsible for overseeing the configuration and maintenance of the Veeva Vault platform to support regulatory publishing and RIMS maintenance activities.

Key Responsibilities:
  • Manage platform services
  • Plan, implement, validate, and test Veeva releases with impact assessment
  • Conduct training sessions and demos to the team following Veeva releases impacting end users
  • Manage day-to-day incidents
  • Coordinate with Veeva for platform or product-level issues
  • Propose lean processes to reduce and minimize ticket issues raised by the team through training and trend analysis
  • Manage change and internal release management
  • Configure permissible changes such as workflows, lifecycle states, security, and CVs
  • Generate reports and dashboards
  • Create new reports and update existing reports as necessary
  • Develop dashboards and update existing ones as needed
  • Work methodically with attention to detail ensuring data anomalies are highlighted
  • Manage access control aligned with governance models for data management
  • Support user adoption of Vault RIMS functionality
  • Implement functional processes within Pharmanovia Vault using checklists or work instructions
  • Provide regular monthly training on gaps and deficiency areas identified
  • Offer ad-hoc and on-demand training
About You:

Candidates with around ten years of experience in regulatory information/data systems management, ideally on the Veeva Vault platform within the pharma/CRO/CMO environment, should have the required skills and experience. We also look for:

  • A Bachelor's degree in a scientific or health-related field, Computer Science, Information Technology, or a related field
  • Relevant certifications in Veeva Vault administration or related areas
  • Full professional proficiency in English (written and verbal)
  • Excellent knowledge of the Veeva Vault platform or similar document management systems in configuration and support, gained within pharma, CRO, CMO, or similar organizations
  • Strong knowledge of MS Word, Excel, PowerPoint, Project, and Outlook
  • Experience with cloud-based platforms and SaaS preferred
  • Basic understanding of software validation and testing, as well as Agile methodology
  • Strong understanding of documentation management concepts and practices, particularly in the life sciences industry
  • Proficiency in system configuration and customization
  • Experience in compliance and maintaining product lifecycle databases and RIM systems
  • Desirable experience in GxP topics
  • Ability to resolve problems independently and skilled at troubleshooting
  • Ability to work in a cross-functional team in a fast-paced environment with multiple competing tasks and demands
  • Excellent communication skills with stakeholder management
What We Offer:

We provide a competitive salary plus bonus and rewards package including holiday, health and wellbeing program, employee recognition awards, social events, pension scheme, and hybrid working.

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