The role involves formulating, leading, and driving global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance
Job Summary
The role involves formulating, leading, and driving global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance.
Key responsibilities include leading and implementing global CMC submission activities, authoring/reviewing high-quality CMC documentation, and representing the department in cross-functional project teams.
Novartis offers a market-competitive base salary, an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options, and worldwide career opportunities.
Matching Summary
The role involves formulating, leading, and driving global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance.
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
global CMC regulatory strategy
global CMC submission activities
authoring and reviewing CMC documentation
Health Authority interactions and negotiations
Nice-to-have
innovation and business benefit
cross-functional project teams
learning and development options
Key Requirements
Science degree or equivalent
Minimum 5 years regulatory CMC experience
Demonstrated knowledge of regulatory submission processes
Ability to deal with complex CMC regulatory issues