1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
Your responsibilities include but not are limited to:
• Manages medium to small level global regulatory submission projects. Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Managing projects end to end to define regulatory strategy for the regulatory submissions where required. Identify content, quality and/or timelines issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
• Identify the required documentation for regulatory submissions and negotiate the delivery of approved source documents in accordance with project timelines.
• Author high-quality CMC documentation (dossiers) as per Regulatory guidelines, applying CMC regulatory strategies (wherever needed), assuring technical consistency and regulatory compliance, meeting defined timelines and e-CTD requirements.
• Developing professional expertise, applies company policies & procedures to resolve a variety of issues. Frequent internal company and external contacts. Represents organization on specific projects. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Refers to established policies & procedures for guidance.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Establish and maintain sound working relationships with stakeholders, partners, and customers.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What You’ll bring to the role:
• University or College Degree in any field or life science with relevant industry experience or comparable degree Good communication in English (oral and written).
• At a minimum 4 years’ experience in the Pharmaceutical area, specifically in Regulatory CMC
• Experience in the Regulatory CMC, area is preferred, Module 3 submissions
• Organizational awareness and experience working cross-functionally and in global teams is a plus
• Ability to work under pressure, demonstrating initiative and flexibility
• High level understanding of Regulatory quality, standards and policies.
• Attention to detail and quality focused
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network