Job Description Template for:
Regulatory Technology ManagerYears of experience: 3 - 7 years
- Bachelor's degree in computer science or relevant fields.
- Master's degree in computer science or relevant fields.
- 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.
- 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.
- 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.
- International experience is desired.
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