Job Description Summary
Regulatory Affairs Manager/Фахівець з реєстрації лікарських засобівSandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
Job Purpose:
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.
Job Description
Your Key Responsibilities:
Regulatory Lifecycle Management: Lead and execute all regulatory procedures for assigned products (e.g., new registrations, variations, renewals), including document preparation, coordination, submission, and follow-up with health authorities.
Artwork Coordination: Manage the full regulatory artwork lifecycle for assigned products, ensuring timely updates aligned with regulatory requirements and availability for production.
Compliance and Database Accuracy: Ensure timely maintenance of internal and external regulatory databases (e.g., State Inspection records) to reflect accurate, up-to-date, and compliant information.
Cross-functional Collaboration: Serve as the regulatory point of contact for assigned products, collaborating closely with QA, Supply Chain, Medical, and Commercial teams.
KPI Reporting: Monitor and report progress against key regulatory timelines and performance metrics.
What You’ll Bring to the Role:
Minimum of 2 years of relevant 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.
Very good knowledge of written English is required.
You’ll receive:
Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.
In addition to the various learning opportunities, we offer company benefits, such as:
28 days of annual leave
Annual bonus
Flexible working arrangements
Corporate psychological support
Parental leave
Life and Health Insurance
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, 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 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 supported!
Skills Desired
Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory ComplianceTop Skills
What We Do
Sandoz is the global leader in generic and biosimilar medicines.
Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.
We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
