Job Description SummaryAs a member of our Global Regulatory Affairs CMC team, your role would be to provide global CMC regulatory strategic and operational direction and documentation for biosimilar projects and products covering development, registration and approval/post approval activities.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!Your key responsibilities:Your responsibilities include, but are not limited to:Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for biosimilar products.Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.Prepare and communicate CMC risk management assessments and lessons learned on major submissions.Initiate and lead Health Authority interactions and negotiations.Please note that this position is limited for 2 years, but we strive to be able to offer a permanent position upon the end of this contract. The position is based in Kundl, Austria, and requires on-site presence for at least 50%.What you’ll bring to the role:Essential Requirements:Good oral and written communication skills with a collaborative and patient-focused mindset.Ability to work successfully with global project teams and prioritize activities considering timelines and workload.Well-developed planning, organizational, negotiation, problem solving and interpersonal skills.Computer/IT systems literacy.Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.Ideally, at least 2 years’ experience in regulatory and/or in the pharmaceutical industry; working knowledge in regulatory submissions desirable.Demonstrated working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge/experience of regulations, guidelines and product life cycle maintenance desirable.Ability to critically evaluate data from a broad range of scientific disciplines.Fluent in English (oral and written), German is an advantage.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.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#SandozSkills Desired: Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance
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