Regulatory Alliance Manager

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!

Responsible for:

Administrative, regulatory, product related services and support to internal and external stakeholders in markets worldwide for API and FDF related inquiries. Regulatory alliance with Global RA functions for strategy and execution of regulatory projects with API and FDF customers in markets worldwide.

• Acts as a single point of contact for all customer related regulatory topics. Provide expert guidance in developing regulatory strategies for specific business opportunities in alignment with Global RA functions.
• Represents B2B in the local and global Sandoz regulatory setup.
• Provides cutting-edge regulatory, technical, quality/product related services to API and FDF customers.
• Monitors internal and external business drivers and coordinates sites/product related resources (RA, Production, QA functions) to fulfil requirements from regulatory authorities and customers with API/FDF related inquiries.
• Expands and maintains a network of contacts in all relevant production sites and with internal and external technical and regulatory experts.
• Acts as a service expert in B2B with detailed regulatory, technical, process and quality know how.
• Secures adherence to quality systems, internal guidelines, customer needs and local market regulations in countries worldwide.
• Is responsible for regulatory compliance, for timely submissions / approvals of new marketing authorizations and variations to existing marketing authorizations with the customers.

What you’ll bring to the role:

At least 3-5 years in regulatory roles in the pharmaceutical industry; good communication skills and preferably with experience in direct customer contact. Good negotiation skills.

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!

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