MRC Manager / Regulatory Affairs Manager (m/f)- FTC

Area of Responsibility
MRC Manager / Regulatory Affairs Manager (m/f)- FTC, Unterach am Attersee by Salzburg, Austria

500 million! That is how many patients we reach with our products every year, improving their lives. It is our aim to expand this to more than 1 billion – with your help and contribution as a MRC Manager (m/f) in our team.

Your Responsibilities:

Your responsibilities include, but not limited to:
• Ensure alignment across global and local functions in regards to strategy and direction for timely preparation of high quality drug product Quality (CMC) documentation to support regulatory new submission.
• Write high-quality CMC documentation for marketed products to obtain rapid and advantageous registrations of changes and routine maintenance such as renewals and variations. Respect agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance.
• Prepare CMC responses to health authority questions during product registration and lifecycle
• Contribute as CMC expert to technical project team decisions during product lifecycle
• Identify the required documentation for submission and coordinate the availability of approved technical source documents in accordance with project timelines
• Support and/or run MRC related projects

What you’ll bring to the role:
• Academic degree in life sciences (Chemistry, Biochemistry or equivalent area)
• Understanding of and curiosity for regulatory requirements within the pharmaceutical industry (CMC filings worldwide and critical evaluation of emerging requirements)
• Ability to meet deadlines and deal with change and high-pressure situations
• Strong communication skills in German and English

Desirable requirements:
• Working knowledge of CMC documentation and change control process preferable
• Hands on personality, fast learner, ability to work in teams (also cross-functional)

Contact: Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner, +44 7525 702920

Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of the respective amount according to the Austrian collective agreement (at least € 45,792.46 per year on a full time basis), plus a potential market oriented excess payment.

We are Novartis. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

EBEWE Pharma Ges.m.b.H. Nfg.KG
Mondseestraße 11
A-4866 Unterach am Attersee