Novartis is seeking a Manager for Regulatory Affairs in Cell & Gene Therapies, located in Schaftenau, Austria. The role entails leading global CMC regulatory strategies and overseeing documentation for Health Authority submissions, along with engaging in negotiations with health authorities
Job Summary
Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Cell & Gene Therapy modality projects/products.
Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
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 within the Novartis group.
Matching Summary
Match Score: 85
Novartis is seeking a Manager for Regulatory Affairs in Cell & Gene Therapies, located in Schaftenau, Austria. The role entails leading global CMC regulatory strategies and overseeing documentation for Health Authority submissions, along with engaging in negotiations with health authorities.
Salary
Base: €65,605.54 /year; Bonus/Equity: attractive incentive program; Benefits: modern company pension scheme, childcare facilities, learning and development options
Skills & Requirements
Must-have
CMC regulatory strategy
Health Authority submissions
regulatory compliance
Chemistry, Manufacturing and Controls
Nice-to-have
innovation
cross-functional teams
risk management assessments
lessons learned
Key Requirements
Science degree or equivalent
At least 2 years' experience in regulatory CMC
Knowledge of regulations, guidelines and product life cycle