Job Description Template for:

Regulatory Technology Manager

Years of experience: 3 - 7 years
Education:
  • Bachelor's degree in computer science or relevant fields.
  • Master's degree in computer science or relevant fields.
Responsibilities:
  • Provides recommendations in formulating new technology and guidance.
  • Establishes, updates and implements Regulatory-required formats, templates, policies, standards, and procedures for regulatory submissions.
  • Ensures that GRA requirements are incorporated and supported by both new systems and upgraded to existing systems.
  • Maintains up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, IDMP; Publishing standards and analyzes new and revised guidance, advises regulatory management of new requirements, and recommends course of action.
  • Provides recommendations on the approach for the application of expert knowledge of global regulatory requirements for systems or policies with all contributing functions that ensure submission compliance.
Required Skills & Qualifications:
  • Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
  • Strong interpersonal, managerial and organizational skills.
  • Strong technical and problem-solving skills.
  • Self-motivated.
  • Ability to work on complex projects and timelines in a matrix team environment.
  • Strong attention to detail and accuracy is a must.
  • Knowledge of process development methodologies.
  • Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
Desired Skills & Qualifications:
  • International experience is desired.


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