RA Manager

Job Description Summary

Regulatory Affairs Manager/Фахівець з реєстрації лікарських засобів

Sandoz 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.

Join us

Skills Desired

Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

---