Nps Associate

**Summary**:

- Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

**About the Role**:
**Major accountabilities**:

- Achieve the best product registration with commercially attractive labelling in accordance with registration plan
- Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance
- Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.)
- Foster and maintain good relations with internal and external stakeholders
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products according Global timelines
- RA Support in MAP/PSDS
- RA Policy handling
- Training curricula review and GOPs applicability

**Key performance indicators**:

- Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Novartis policy and guidelines

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

- Functional Breadth.
- Cross Cultural Experience.
- Operations Management and Execution.
- Project Management.

**Skills**:

- Analytical Skill.
- Clinical Trials.
- Collaboration.
- Detail Oriented.
- Lifesciences.
- Project Planning.
- Regulatory Compliance.

**Languages**:

- English.

Division

Development

Business Unit

Pharmaceuticals

Location

Chile

Site

Santiago

Company / Legal Entity

CL01 (FCRS = CL001) Novartis Chile S.A.

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.