Global Labeling Manager (d/f/m)

Job title:

Global Labeling Manager (d/f/m)

Company

Novartis

Job description

Job Description Summary -Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission.Job DescriptionSandoz 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 applicableMaintain core SmPC/PIL/Label based on CMC or administrative changesDefine submission strategy for EU and interact with Health Authority as neededServe as a strategic partner for internal stakeholders from regulatory affairs, pharmacovigilance, medical, country organizations, and other relevant functionsProvide labeling input for aggregate reports, Risk Management Plans (RMPs) and other relevant documentsRepresent global labeling team in internal (safety) boardsSupport 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 informationStrong inter-personal and communication skills with a high compliance/quality mindsetAttention to detailsFluent Business EnglishDesirable requirements:Ability of leading in a matrix organizationExperience in generic and originator portfolioWhy 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.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:#SandozSkills Desired Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance

Expected salary

Location

Kundl, Tirol

Job date

Fri, 01 Nov 2024 00:23:55 GMT

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