Registration Manager (d/f/m)

at  Sandoz

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!

Your key r esponsibilities:

• 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
• Good oral and written communication skills with a collaborative and patient-focused mindset
• Fluent Business English

IMAGINE WHAT YOU COULD DO HERE AT SANDOZ!

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.
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 € 64.023,54/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. We are open for part-time and job sharing models and support flexible and remote working where possible.

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
• Good oral and written communication skills with a collaborative and patient-focused mindset
• Fluent Business Englis