Regulatory Affairs Specialist
hace 2 meses
Job ID- 380487BR- Aug 03, 2023- Chile**Job Description**:
- 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.
**Diversity & Inclusion / EEO**:
- 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
Location
Chile
Site
Región Metropolitana
Company / Legal Entity
Novartis Chile S.A
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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