About the role

As Regulatory Affairs Manager, you will be responsible for all drug regulatory affairs matters for the assigned indication group and will act as an interface between global Regulatory Affairs departments and Swissmedic to obtain new marketing authorizations as well product lifecycle maintenance, support new product launches, ensure regulatory compliance and support Pharmacovigilance activities.

Responsibilities will include, but are not limited to:

• Preparation of the regulatory strategy for new submissions
• Timely submission of new products to Swissmedic in agreement with the yearly target
• Obtain marketing authorizations in accordance with the yearly target.
• Drive product lifecycle maintenance to ensure regulatory compliance.
• Participate in Product Cross Functional Teams as required, providing close regulatory support and strategic business partner to Launch, Portfolio, Quality Assurance, Supply Chain, Marketing, Medical, Market Access, Commercial departments and other Global Regulatory Groups
• Check Swissmedic updates and follow trends in the regulatory environment and legislation, ensuring awareness and alignment within the department, in order to meet future requirements on time.
• Signal notification to Swissmedic and support Pharmacovigilance activities
• Always work in accordance with Good Regulatory Practice

Role Requirements

• Education: Pharmacist or natural scientist preferably with medical background
• German (fluent), English (advanced) French (desirable) and Italian (an asset)
• Minimum 3-5 years Regulatory experience; experience in Biosimilars is advantageous.
• Experience and know-how in Drug Regulatory Affairs and project management.
• Knowledge of Swiss regulations and guidelines, Quality Assurance, Pharmaceutical Technology and Pharmacovigilance
• Agile and strategic mindset, solution oriented, continuously challenging the status quo to achieve overall business targets.
• Understanding of market structures and business impact of actions.
• Emphatic, powerful, courageous, visionary, resilient and team spirit, you will be a pro-active team member who shows flexibility in a changing environment and always strives for excellent results.

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 500 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!

Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and accommodation
Sandoz is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, please send an e-mail to claire.gratton@sandoz.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
#Sandoz

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Regulatory Affairs Manager (d/f/m) 100%