Job Description Template for:

Regulatory Technology Manager

Years of experience: 3 - 7 years
Education:

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:

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