Regulatory Affairs Expert

328592BR
Oct 08, 2021
Spain

Job Description

To learn more about Novartis Spain, visit: http://www.novartis.es/
Your responsibilities include, but are not limited to:
• 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.
• Manages medium to small level global regulatory submission projects.
• Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• Write, edit and /or manage the production of high quality clinical documentation (e.g. Clinical Study Reports & Summary Documents) for submission to regulatory authorities in support of marketing applications.
• Developing professional expertise, applies company policies & procedures to resolve a variety of issues. .
• Frequent internal company and external contacts. Represents organization on specific projects
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Refers to established policies & procedures for guidance. -Contributes to some cost center goals & objectives

Diversity & Inclusion / EEO

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

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Global Drug Development
REG AFFAIRS GDD
Spain
Barcelona
Research & Development
Full Time
Regular
No
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328592BR

Regulatory Affairs Expert

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