Regulatory Affairs Specialist

hace 4 semanas


Santiago de Chile Novartis A tiempo completo

2023 will potentially see Sandoz become a standalone organization Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally Together we will shape the future of Sandozare you ready to make a difference?
Sandoz #Chile #DRA #Biosimilars
Major responsibilities of the role:

- 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**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

QF academic background,
Operations Management and Execution Project Management Collaborating across boundaries Functional Breadth
Cross Cultural Experience
English

**Division**

SANDOZ

**Business Unit**

Commercial OPS SIR SZ

**Country**

Chile

**Work Location**

Región Metropolitana

**Company/Legal Entity**

Novartis Chile S.A

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No



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