Regulatory CMC Manager
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Walker Cole is searching for a Regulatory CMC Manager to join an exciting global pharmaceutical business to work across development and life cycle management. If you have strong Regulatory CMC experience, the ability to communicate well cross-functionally and want to develop your skills across the entire lifecycle please apply below.
A Regulatory CMC Manager will:
- Develop and execute global regulatory CMC strategy across development and marketed products globally.
- Author and manage CMC submissions, including IND/CTA/IMPD/MAA/BLA/NDA and variations.
- Lead global Health Authority interactions
- Life cycle management and post approval activities
A Regulatory CMC Manager will have:
- Strong Regulatory CMC experience, authoring and reviewing M3 dossiers.
- Experience working with external partners and health authorities
- Knowledge of small or biological products
Regulatory // Regulatory CMC // Manager // Authoring //Reviewing // Module 3 // M3 // EU // UK // International // Health Authority // Scientific Advice // EMA // FDA // ICH