Regulatory Affairs Manager; Labeling

Requirements

• Cross-Functional Team collaboration.
• Detail Oriented.
• Labeling Documentation with quality
• Labeling Regulations.
• Operational Excellence.
• Regulatory Compliance.
• 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.
• Join us!
• Skills Desired
• Cross-Functional Teams, Detail-Oriented, Labeling Documentation, Labeling Regulations, Operational Excellence, Regulatory Compliance, Safety

Benefits

Additional Information

Job Description Summary 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! Provides the labeling/artwork strategy, regulatory intelligence and knowledge which are required to develop, market, and maintain products. Provides strategic labeling input and support for global development projects and/or marketed products. Reviews labeling change information, and ensures that it is supported by the data and consistent with the application. Supports and assists the development and participates in negotiations on later stage products with regulatory agencies on approval of label. Monitors, evaluates and recommends improvements to labeling processes, quality, systems tools and/or policies. Job Description Your Key Responsibilities: Your responsibilities include, but not limited to: Performs tasks assigned as per applicable procedures (e.g., GOPs, SOPs, WIs).This includes, but is not limited to CDS and core English SmPC/PIL/Label (in line with CDS and all relevant HA signals) preparation and maintenance Signal Detection & Evaluation: perform external signal detection by monitoring HA websites and/or the reference product label, and enter identified signals into the CDS & SD database. Evaluate signals from any source for their impact on patient safety, and decide on actions to be taken to mitigate related risks. Organization of translations if needed and readability testing of package leaflets. Maintain core SmPC/PIL/Label based on CMC or administrative changes. Define submission strategy for EU and interact with HAs as needed. Ensure in-time hand-over of variation package or response documents to submission teams. Ensure update of internal databases/RIMS. Collaborate with Regulatory Associates and Specialists for assigned tasks to enable timely submissions. Prepare and maintain SOPs/WIs/guidelines as assigned. Maintain documentation and perform administrative actions as required. Support to country organization as appropriate. Support compliance/performance reporting and oversight. Support labelling projects, audit and inspections, and other specific tasks as assigned. Represent global labelling team in internal (safety) boards and present specific topics when needed. What you'll bring to the role: Essential Requirements: Minimum 10+ years of RA experience, including 5-7 years in labeling Scientific academic degree (postgraduate), preferably in natural science (chemistry, pharmacy, biology or equivalent) or Healthcare Professional. Cross Cultural Experience. People Challenges. Functional Breadth. Project Management. Collaborating across boundaries.

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