May 19, 2022

Job Description

Site Regulatory CMC Expert / Medical Devices (f/m/d), Novartis Technical Operations, Schaftenau, Austria

799 million. That’s how many lives our products touched which we’re incredibly proud of, while asking ourselves: how can we continue to improve and extend even more people’s lives?

Come, join Schaftenau site team of many professionals - Regulatory, Manufacturing, Analytics and Development to make a difference and to advance your career. We believe the answers are found when curious, courageous and collaborative people who are empowered to risk failure by taking smart risks & encouraged to share new ideas can open up new ways of making things happen. It is a great opportunity to grow at our manufacturing site with potentially working up to 70% home office.

We are Novartis. Join us and help reimagine medicine.

Your key responsibilities:

Your responsibilities include, but are not limited to:
Drive in an un-bossed way for launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the site specific (global and local) products.

Your responsibilities include, but are not limited to:
• Act as single point of contact and advisor for worldwide regulatory intelligence information on the site for medical devices balance business benefit with regulatory risks
• Provide regulatory strategic & tactical guidance on regulatory requirements and trends including potential regulatory hurdles
• Provide regulatory evaluation of changes and support global CMC submission activities
• Support the timely submissions documentation requirement and any content (e.g. delivery of approved technical source documents)
• Give constructive feedback (review) to ensure high-quality CMC documentation & answers to Health Authorities

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:
• > 4 years’ experience in pharmaceutical manufacturing and/or QA/QC or in technical development
• Minimum 2 years’ experience in Regulatory Affairs (CMC preferable)
• Solid know-how in pharmaceutical technology and project management
• Fluent in English (oral & written)

Desirable requirements:
• Strong Analytical Science Technology or Manufacturing Science Technology background
• Candidates with Regulatory knowledge or Medical Device knowledge would have a clear advantage

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 € 52.204,04/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.

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
Novartis Technical Operations
Full Time
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Site Regulatory CMC Expert / Medical Devices (f/m/d)

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