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Regulatory Data & Systems Manager

Regulatory Data & Systems Manager

ConfidentialHyderabad / Secunderabad, Telangana
26 days ago
Job description

Roles & Responsibilities :

  • System Administration : Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements.
  • Regulatory Business Analysis : Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices.
  • Project Coordination Assist in planning, tracking, and executing departmental projects and initiatives.
  • Stakeholder Communication : Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates.

Required Knowledge and Skills :

  • Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.
  • 5+ years' experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies.
  • Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
  • Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
  • Familiarity with GxP requirements and systems validation.
  • Life Sciences, Biotech or pharmaceutical industry experience preferred.
  • Proven Veeva Vault knowledge.

    • Preferred Knowledge and Skills :

  • Advanced knowledge of Veeva Vault,
  • Familiarity with global regulatory processes and standards.
  • Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.

    • Basic Education and Experience :

  • Bachelor's degree and 2 years of directly related experience
  • Associate's degree and 6 years of directly related experience
  • High school diploma / GED and 8 years of directly related experience

    • Skills Required

    Business Analysis, Sql, Sdlc

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    Regulatory Manager • Hyderabad / Secunderabad, Telangana