Description
REGULATORY CMC SPECIALIST
Location: Greater London
Start Date: ASAP
Rate per hour: up to 55-60 per hour
My client is a global pharmaceutical company. Due to continued growth and the transfer of ongoing compliance projects, my client is looking for a Regulatory CMC specialist/executive to come in and support the manufacturing site transfer work.
Skills and Knowledge Required:
- Detailed proven CMC knowledge and experience for EU and EMAP region
- Able to prepare high quality CMC submissions, eg variations and international dossiers
- Understands CMC regulations, guidelines, procedures and policies relating registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Ability to manage multiple project assignments/teams simultaneously and provide data assessment and conclusions
- Identifies risks associated with submission data and information packages and ability to propose mitigation actions.
- Ability to efficiently interact with customers and senior stakeholders as required
- Identifies improvement opportunities for CMC Regulatory processes, policies and systems.
- Good communication skills and flexible approach: 'can do attitude'