Regulatory Affairs Manager
4 days ago
Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve._
**Minimum requirements**
- Operations Management and Execution Project Management Collaborating across boundaries Functional Breadth Cross Cultural Experience Managing Crises
**Division**
- Global Drug Development
**Business Unit**
- REG AFFAIRS GDD
**Country**
- Egypt
**Work Location**
- Cairo
**Company/Legal Entity**
- NOV PHARMA EGY
**Functional Area**
- Research & Development
**Job Type**
- Full Time
**Employment Type**
- Regular
**Shift Work**
- No
**Early Talent**
- No
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