Regulatory Affairs Specialist

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 Specialist, you will be responsible for coordinating and executing regulatory affairs activities, with a focus on managing variations procedures and overseeing artwork change requests. Your efforts will directly support our mission to improve and extend lives through high-quality pharmaceutical products.

Your Key Responsibilities:

• Variations Regulatory Procedure Management: Oversee the management of regulatory procedures for variations, including coordination, preparation, and timely submission of documents. You will track and report key performance indicators (KPIs) to ensure process efficiency and maintain clear communication with stakeholders.
• Artwork Change Requests Coordination: Direct and coordinate the activities related to artwork changes, ensuring they meet regulatory requirements and are prepared and submitted on time. You will collaborate with local stakeholders to ensure that all artworks are updated and available for production.
• Database Maintenance: Maintain and ensure the accuracy of the State Inspection database with current and compliant artworks.

What You’ll Bring to the Role:

• Minimum of 2 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.
• 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!

Join us!