CMC Regulatory Affairs Director

Walker Cole International are looking for a CMC Regulatory Affairs Director to join an established Pharmaceutical Business in the UK. In this role you will be responsible for the development and execution of CMC regulatory strategy for the business.

As the CMC Regulatory Affairs Director, you will be responsible for:

• The development and creation of the Regulatory plan, regulatory files and tracking databases.
• Collaborating with external consultants and organisations to oversee the execution of regulatory submissions.
• Represent the business as Global/Regional Regulatory Lead for development programs.
• Monitoring the regulatory landscape to adapt to changes that will affect the business' portfolio.

A successful candidate will have:

• A Bachelor's degree in a scientific field with at least 8 years industry experience.
• A strong understanding of the drug product lifecycle from R&D through to marketing.
• A working knowledge of FDA, EMA and ICH regulatory guidelines.
• Extensive Module 3 experience

Regulatory Affairs | RA | Head of Regulatory Affairs| GMP | Pharmaceutical | Regulatory | Submission | Product Dossiers | EU | Global | MHRA | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module 3 | Module 4 | Module 5 | TMF | Trial Master File | Clinical | R&D