Ra Cmc Submission Coordinator

**RA CMC Submission Coordinator - Biosimilars (M/F/d), 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 pa-tients’ 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 sub-missions.

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

- Perform compliance and operational support including QC checks and compliance/ reg-ulatory database entry and reports
- Create submission documentation such as folders, metadata forms, RA request forms
- Ensure documentation is eCTD compliant, Document formatting (DA) checked, finalized and eCTD filenames assigned
- Coordinate data/KPIs required for reports within RA CMC
- Coordinate, prepare and track CMC submissions
- Acquire and maintain documents required for RA CMC submission in the Document Management System

**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
- Computer literacy/IT systems literacy: Excellent data processing skills
- Fluent English required (oral and written). Good written/spoken communication skills

**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 € 52204,04/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

**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**

Regular

**Shift Work**

No

**Early Talent**

No