Regulatory Affairs CMC Lead
This is a dynamic role within our Global Regulatory Affairs organization, where you will drive regulatory strategy for pharmaceutical products and vaccines across their lifecycle.
Main Responsibilities
* Develop and implement global regulatory CMC strategies.
* Create strategies for development and marketed products focusing on chemical entities, biological entities, and/or vaccine products.
* Serve as the primary point of contact for regulatory authorities including FDA and EMA.
About You
To be successful in this role, you should have experience of at least 4 years in CMC regulatory roles, contributing to regulatory filings and implementation of regulatory strategies.
Proven ability to respond to health authority questions and prepare regulatory documentation. Strong understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.
Benefits
You will have the opportunity to play a crucial role in bringing innovative therapies to millions worldwide by working at the forefront of drug discovery and development with a patient-centric approach.
Leverage advanced AI, data, and digital platforms to push the boundaries of pharmaceutical science and regulatory strategy. Engage with diverse teams spanning scientific, clinical, and digital fields, fostering breakthroughs through cross-functional collaboration.