500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 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.
Independently, establish and drive strategic and operational global CMC regulatory direction and documentation for Biosimilars projects/products covering development, registration and approval/post approval activities. Make informed regulatory decisions, balancing patient and business risks and benefits leading to timely Health Authority approvals. As an experienced member of department, facilitate consistency within the CMC regulatory documentation by providing regulatory advice within and outside the department.
Your Responsibilities include, but are not limited to:
• Formulate, lead and drive global CMC regulatory strategy for Biosimilars modality projects/products drawing on substantial regulatory expertise with a focus on innovation, maximizing the business benefit balanced with regulatory risks and compliance
• Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions
• Identify the required documentation and any content, quality and/or timeliness 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 Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
• Represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnerships with stakeholders
• Initiate and lead Health Authority interactions and negotiations: setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Establish and maintain a single point of contact with FDA
• Provide strategic advice and direction within the department and cross-functionally through specialized assignments
Diversity & Inclusion / EEO
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.
What you'll bring to the role:
• Education: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired
• Minimum 8 years regulatory experience preferred and/or pharmaceutical industry experience
• Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements
• Proven ability to critically evaluate data from a broad range of scientific disciplines.
• Demonstrated track record to successfully lead/work in interdisciplinary global teams; leading, planning and prioritizing activities simultaneously on multiple projects.
• Demonstrated ability for innovative and big picture thinking.
• Strong planning, negotiation, organizational and interpersonal skills.
• Excellent written/spoken communication, and negotiation skills
Why consider Sandoz?
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:
Novartis 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 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:
Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.