Job Description Summary
The Global Labeling Manager is a member of the global labeling team within Sandoz Regulatory Affairs, who is responsible for maintaining and updating core English Summary of Product Characteristics (SmPC), Package Leaflet (PIL), and Labels for small molecule products, ensuring compliance with relevant standards, signals from Health Authorities, and reference product labels. The role entails defining submission strategies for the European Union (EU), collaborating with Health Authorities, and serving as a strategic partner to internal stakeholders from various departments. The Global Labeling Manager also provides labeling input for aggregate reports, Risk Management Plans (RMPs), represents the global labeling team in internal boards, and supports audits/inspections as well as guidance document authoring.
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!
Key responsibilities:
Responsibilities include, but are not limited to:
Maintain core English Summary of Product Characteristics (SmPC)/Package Leaflet (PIL)/Label for small molecules (generics and non-generics) in line with CDS, relevant Health Authority signals/triggers and reference product labels, if applicable
Maintain core SmPC/PIL/Label based on CMC or administrative changes
Define submission strategy for EU and interact with Health Authority as needed
Serve as a strategic partner for internal stakeholders from regulatory affairs, pharmacovigilance, medical, country organizations, and other relevant functions
Provide labeling input for aggregate reports, Risk Management Plans (RMPs) and other relevant documents
Represent global labeling team in internal (safety) boards
Support audits/inspections and internal guidance document authoring as Subject Matter Expert (SME)
What you’ll bring to the role:
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 (EU SmPC/PIL, CDS)
Good understanding of drug safety information
Strong inter-personal and communication skills with a high compliance/quality mindset
Attention to details
Fluent Business English
Desirable requirements:
Ability of leading in a matrix organization
Experience in generic and originator portfolio
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.
We are open for part-time and job sharing models and support flexible and remote working where possible.
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.
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: Job search | Sandoz
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Skills Desired
Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory ComplianceGo Premium: Access the World's Largest Selection of Remote Jobs!