Ra Cmc Submission Coordinator

Vor 4 Tagen

Langkampfen T, Österreich Novartis Vollzeit

**RA CMC Submission Coordinator (f/m/d) - temporary for 2 years, Global Drug Development, Schaftenau, Austria**

582 That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients’ lives and we need your support. As a member of our Global Regulatory Affairs CMC team, your role would be to provide operational support to guarantee timely preparation of high-quality CMC regulatory submissions.

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Support project teams with the coordination, preparation and tracking of CMC (Chemistry, Manufacturing, Control) submissions
- Create, acquire, maintain, format and finalize documents in the document management system for health authority submission
- Perform compliance and operational support including quality and compliance check of regulatory database entry and reports
- Create submission documentation such as document folders, metadata forms, request forms
- Ensure documentation is compliant with electronic Common Technical Document (eCTD) requirements
- Coordinate data/Key Performance Indicators required for reports within the department

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**

**What you’ll bring to the role**:

- Effective planning, organizational and interpersonal skills
- Good written/spoken communication skills
- Fluent English required (oral and written)
- Computer literacy/IT systems literacy with regards to data processing skills/knowledge
**Desirable requirements**:

- Education: General qualification for university entrance (Matura) or bachelor degree
**Why Novartis?**769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying

**Imagine what you could do here at Novartis**In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 37.756,32/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.

**Commitment to Diversity & Inclusion**:Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.

**Division**

Global Drug Development

**Business Unit**

REG AFFAIRS GDD

**Country**

Austria

**Work Location**

Schaftenau

**Company/Legal Entity**

Sandoz GmbH

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Temporary

**Shift Work**

No

**Early Talent**

No

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