Regulatory Affairs Senior CMC Manager – Cell and Gene Therapy
- East Hanover, NJ
576! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients' lives and we need your help. As senior manager, you independently provide strategic and operational global CMC regulatory direction and documentation for our products covering development and post-approval activities. You bring a foundation of regulatory knowledge regarding drug development, manufacturing, and analytical testing, as well as a collaborative and patient-focused mindset.
Your Responsibilities include but are not limited to:
• Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Cell and Gene Therapy projects/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 partners. Represent department in cross-functional project teams
• Lead, prepare and communicate CMC risk management assessments and lessons learned on major submissions
• Initiate and lead Health Authority interactions and negotiations.
EEO Statement 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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
What You'll Bring To The Role
• Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired
• Minimum 5 years of regulatory CMC experience and/or pharmaceutical industry experience
• Ability to handle complex CMC regulatory challenges and requirements while leading/working in interdisciplinary global teams
• Well-developed planning, organizational, negotiation, problem solving and interpersonal skills
• Strong oral and written communication skills with a collaborative and patient-focused attitude
• Computer/IT systems literacy
• Proven 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 fields
Why consider Novartis?
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
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.
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