Zum Hauptinhalt springen

RA CMC Submission Coordinator (f/m/d)

Job Description

RA CMC Submission Coordinator (f/m/d), Schaftenau, Tyrol, 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:
• Perform compliance and operational support including document quality checks and compliance/ regulatory database entry and reports
• Create submission documentation such as folders, metadata forms, Regulatory Affairs request forms
• Ensure documentation is eCTD compliant, and correct eCTD filenames are assigned
• Coordinate data/KPIs required for reports within RA CMC
• Coordinate, prepare and track CMC submissions to health authorities
• Perform super-user role of RA CMC documentation system/ support super-user for e.g. account requests
• Support other Coordinators, Experts and Managers for end-to-end submission coordination

Diversity & Inclusion / EEO

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:
Essentials:
• General qualification for university entrance (Matura) or bachelor's degree
• 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:
• Proficiency in German (oral and written)
• Preferably two years in regulatory and/or experience in the pharmaceutical industry
• Ability to work successfully with global project teams and prioritize activities considering timelines and work

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, 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 €49,804.58 per 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.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

RA CMC Submission Coordinator (f/m/d)

Langkampfen
Vollzeit

Veröffentlicht am 15.11.2022

Jetzt Job teilen


Bewerbungen von Menschen mit Behinderungen oder chronischen Erkrankungen ausdrücklich erwünscht!

Unternehmen, die mit myAbility.jobs zusammen arbeiten sind von den Fähigkeiten von Menschen mit Behinderungen überzeugt.