Regulatory Affairs Manager

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic 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!

Regulatory Affairs Manager / Фахівець з реєстрації лікарських засобів

As a Regulatory Affairs Manager, you will be responsible for selective Regulatory Affairs activities within the RA department. Your main goal will be to support obtaining and maintaining marketing authorizations and ensuring regulatory compliance.

Your Key Responsibilities:

• Regulatory Procedure Management: Manage various regulatory procedures (e.g., variations, renewals, new submissions) including coordinating, preparing, and assuring timely submission. Track and report KPIs, and ensure communication with stakeholders.
• Artwork Management: Oversee and coordinate all activities to ensure timely preparation and submission of artworks aligned with regulatory requirements in Ukraine, available for production, and relevant to local stakeholders.

What you’ll bring to the role:

• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
• Strong planning, organizational, and communication skills.
• Attention to detail and result-oriented mindset.
• Ability to multitask and thrive in a fast-paced environment.
• Fluent in (or very good) English.

You’ll receive:

Wide range of benefits, including flexible working, learning and development opportunities, access to mental health programs, reward programs (annual), life and health insurance.

Work regime: hybrid (office/home)

Location: Kyiv (Ukraine), remote is not possible.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 800 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!