Global Labeling Manager / Safety Label Updates

Global Labeling Manager / Safety Label Updates (d/f/m)

Full time

Kundl (Sandoz), Austria

Job Description Summary

The Global Labeling Manager, Safety Label Updates, is a member of the global labeling team within Sandoz Regulatory Affairs, fulfilling multiple responsibilities related to safety information management for the entire Sandoz product portfolio. This includes identifying new safety information from defined sources, entering it into an internal database, and assisting in the creation and updating of a central document called the Core Data Sheet (CDS) that contains essential safety information. The role also involves acting as a Subject Matter Expert for safety-related Health Authority requests, supporting audits and inspections, and ensuring regulatory compliance with a focus on deviation management.
 

Job Description

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.

Join us as a Founder of our ‘new’ Sandoz!

Your key responsibilities:

Your responsibilities include, but are not limited to:

• For the entire Sandoz product portfolio, identify new safety information from defined sources, including health authority webpages
• Enter detected new safety information in internal database
• Support timely creation and update of Core Data Sheet (CDS), a central document, which contains all the essential safety information on a product
• Act as Subject Matter Expert (SME) for safety related Health Authority requests
• Liaise with internal stakeholders from regulatory affairs, pharmcovigilance, medical, country organizations and other relevant functions
• Support audits/inspections on safety label screening and internal guidance document authoring as SME
• Ensure regulatory compliance, including deviation management

Essential Requirements:

• Scientific academic degree (MSc, PhD or comparable degree), preferably in natural sciences (chemistry, pharmacy, biology or equivalent)
• Ideally, at least 4-5 years’ experience in regulatory and / or in the pharmaceutical industry, including 2 years in regulatory labeling
• Good understanding of drug safety information
• Attention to details
• Strong inter-personal and communication skills with a high compliance/quality mindset
• Fluent Business English

Desirable requirements:

• Ability of leading in a matrix organization
• Experience in safety label change trigger detection (EU HA and originators)

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!

Imagine what you could do here at Sandoz!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as 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 € 64.023,54/year (on a full time basis). In most cases, 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.

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.

#Sandoz

Skills Desired

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