RA Senior Specialist (d/f/m) – Global Labeling Biopharma | Kundl, Austria

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape!

Are you passionate about shaping the future of medicines through strategic regulatory labeling? Do you thrive in a collaborative, cross-functional environment and have a keen interest in digital tools and AI? Join our dynamic team in Global Labeling Biopharma, where we drive regulatory excellence across the product lifecycle—from development to post-authorization.

Your Key Responsibilities:

Your responsibilities include, but are not limited to:

• Develop and implement global labeling and artwork strategies for both investigational and marketed products, ensuring alignment with regulatory requirements and product development timelines.
• Provide regulatory input into safety risk communication and portfolio stewardship initiatives, with a focus on labeling implications.
• Conduct comprehensive assessments of labeling topics, including comparative analysis of reference and competitor product labeling, regulatory frameworks.
• Evaluate country-specific labeling to identify deviations from the Company Core Data Sheet (CCDS) and facilitate cross-functional discussions for resolution.
• Author and review high-quality regulatory documentation, including responses to Health Authority queries related to labeling content.
• Support regulatory negotiations and interactions with Health Authorities to facilitate approval of proposed labeling updates.
• Continuously monitor and contribute to the enhancement of labeling processes, quality standards, and digital systems/tools.
• Collaborate effectively with cross-functional stakeholders including Regulatory Affairs, Pharmacovigilance, Medical Affairs, and Commercial teams to ensure labeling consistency and compliance.
• Represent the Global Labeling function in cross-functional project teams and regulatory forums, contributing subject matter expertise and strategic insights.

What you’ll bring to the role:

Essential Requirements:

• Scientific academic degree (MSc, PhD or comparable degree), preferably in natural sciences (pharmacy, biology, chemistry or equivalent)
• Experience in regulatory affairs, especially in labeling, is a valuable asset and would be advantageous, though not essential
• Strong communication and presentation skills.
• Ability to think critically and embrace change.
• Interest in digital tools, automation, and AI to enhance regulatory processes.
• A collaborative mindset and ability to work across functions and cultures.

You´ll receive:

• Attractive salary with incentive program
• Modern company pension scheme
• Flexible working hours / home-office depending on the position
• 14 weeks of paid parental leave
• Additional days off (bridge-days)
• Subsidized meals in our canteen
• Sustainable mobility in the form of company transportation, shift buses and car sharing
• Company Kindergarden and summer camps for children
• Wellbeing & mental health offers
• Learning and development options for your personal and professional growth
• Worldwide career opportunities

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 59.781,96/year (on a full-time basis).

In most cases, however, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every 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 are 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!

Are you ready to join us? Then we look forward to your application!

Commitment to Diversity & Inclusion:

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

If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at jobs.austria@sandoz.com.