Senior Regulatory Executive - CMC
The headquarters of a major pharmaceutical company require a Senior Regulatory Executive with experience in Chemistry, Manufacturing and Control (CMC) to manage the regulation of their global product base.
You will be authoring regulatory documentation and providing regulatory advice and expertise to global markets regarding mature products. Your detailed CMC knowledge across EU and emerging regions will be vital for the registration and manufacturing of vital pharmaceutical products around the world. This is a highly varied role involving liaison with numerous departments globally as well as external regulatory bodies.
Your responsibilities will include:
- Authoring detailed regulatory documentation for mature drug products
- Using extensive experience of CMC regulatory processes to guide and continue improve on operations
- Interacting with consumers and senior stakeholders to contribute to regulatory projects
- Manage multiple projects at once, demonstrating exceptional problem solving skills
- Responding to manufacturing site change controls
The ideal candidate has demonstrable experience authoring CMC documentation for mature products and excellent written and verbal communication skills. They are self-starter who understands CMC regulations on a global scale.
This role is initially a 12 month contract but there is excellent scope for renewal.
If you are interested in this role or are looking for a role in the scientific or pharmaceutical industry, please contact Siobhan O’Brien on [email protected] to discuss this further.