Registration Manager Rcc

6 maanden geleden

Almere, Nederland Sandoz Voltijd

**Major accountabilities**:

- As a specialist, responsible for regulatory affairs excellence and compliance activities in an assigned unit/ portfolio -Actively participates in providing process excellence support to RA groups -Key stakeholder and Point Of Contact(POC) for internal global audits as well as assigned external audits -Actively provides support to assigned region/cluster/country with internal audit and external inspection preparation and CAPA proposals as needed.
- Creates relevant remedial and improvement actions for Corrective Action Plans from Audits/Inspections -Tracks, reports and follows-up on completion and implementation of relevant tasks to ensure closure of audit observations.
- Tracks and reports deviations/incidents in the appropriate systems together with RA groups -Responsible for implementation of new processes, policies, metrics and appropriate training.
- Ensures data compliance -Partners with cluster/country Liaison group, to implement and track cluster/country related trainings related policies, processes and procedures.
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

**Key performance indicators**:

- Fully compliant portfolio with internal and external regulations and procedures -Adherence to Novartis policy and guidelines -Stakeholder/ project feedback

**Minimum Requirements**:
**Work Experience**:

- Cross Cultural Experience.
- Project Management.
- Operations Management and Execution.
- Collaborating across boundaries.

**Skills**:

- Auditing.
- Compliance Risk.
- Data Analysis.
- Operational Excellence.
- Project Management.
- Regulatory Compliance.
- Regulatory Reporting.

**Languages**:

- English.

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