DRC / Regulatory Affairs CMC Manager (m/f/d) - temporary (2 years)
Regulatory Affairs CMC / Development Regulatory Center Manager (m/f/d) -temporary (2 years), Kundl, Austria
9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.
Your responsibilities include, but not limited to:
• Contribute as Development Regulatory Center (DRC) Manager Chemistry, Manufacturing and Controls (CMC) expert to technical project teams during product development
• Ensure alignment across global and local functions with regard to strategy and direction for timely preparation of high quality CMC documentation to support new regulatory submissions for complex new product developments and/or for a portfolio of new product development projects
• Independently and proactively identify required documentation for submission and coordinate the availability of approved technical source documents in accordance with project timelines
• Write high-quality CMC documentation according to agreed CMC regulatory strategies, while assuring technical congruency and regulatory compliance, to obtain rapid and advantageous registrations of new products world-wide
• Manage/lead DRC related projects or global initiatives
What you’ll bring to the role:
• Academic degree in life sciences (Chemistry, Biochemistry or equivalent area)
• At least 3 years’ experience in Regulatory Affairs (with a focus on knowledge of CMC requirements)
• Develops and presents strategic regulatory options to internal and external stakeholders
• Demonstrates strong leadership skills, establishes (cross-functional) teams/relationships and maintains them
• Very strong communication skills in English
• German skills would be beneficial
• Knowledge of project management
Contact: Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner, +44 7525 702920
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 51,180.50 per year on a full time basis).
Imagine what you could do at Novartis!
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.