Job Description

About the role

2023, 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, hardworking 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 Sandoz\xe2\x80\xa6 are you ready to make a difference?
Position Purpose:
Manages medium to small level global regulatory submission projects.
Major Accountabilities:
-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. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
-Distribution of marketing samples (where applicable)

Role Requirements

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.
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future, so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an aspiration environment with impact, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!

Functional Area

Research & Development

Division

SANDOZ

Business Unit

NON-NVS TSA SANDOZ GLOBAL DEVELOPMENT

Employment Type

Regular

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.

Shift Work

No

Early Talent

No

Novartis