Walker Cole International are currently searching for a Senior Regulatory CMC Specialist to join an exciting global consumer healthcare business with a portfolio of household name brands. This is an opportunity for somebody with mentoring experience or project & people management to progress their career. Based in Southeast England.
Your responsibilities as a Senior Regulatory CMC Specialist:
* Oversee the authoring and reviewing of CMC documents, coordination and management of global submissions.
* Act as global/regional CMC representative within cross-functional team projects.
* Lead the preparation of CMC information for submission to global regulatory agencies.
* Line management.
As a Senior Regulatory CMC Specialist, you will have:
* Expertise in Regulatory CMC strategy and authoring, module III.
* Knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance
* Knowledge in handling post approval changes of Solid Oral, nasal sprays and other Dosage.
* Mentoring or line management experience.
CMC // Regulatory // Senior Specialist // Post approval // Senior Regulatory CMC Specialist // Regulatory CMC // Module 3 // OTC // Consumer Healthcare