An exciting new opportunity is available with a global pharmaceutical company to join their regulatory affairs department. The purpose of this role is to oversee all tasks associated with cGMP regulatory reports and protocols.
Key Responsibilities - Regulatory Site Officer
- Review and evaluation of all CMC related activity within regulatory affairs establishing strategy and protocols for continued efficiency in processes
- Ensure any changes in legislation and regulation is applied correctly for site compliance
- Analyse any complex regulatory issues and processes to identify risks effecting site compliance and provide appropriate solutions accordingly
- Deep technical understanding of site GMP documentation, ensuring relevant regulatory body guidelines have been followed and documented accordingly for product approval
- On occasion provide professional advice to site and third party manufacturing partners
- Be responsible for information to support internal and external inspections/audits
- Act as a technical expert, give regulatory advice to other departments and support junior members of staff where necessary.
- Minimum degree qualification in a relevant life sciences subject
- Very good understanding of CTD Module 3 Content and regulatory CMC
- Knowledge and experience applying regulatory legislation to ensure site compliancy
- Demonstrated experience working with quality management systems (Documentum) and cGMP
- Deep technical understanding of drug development process and compliance required for registration
- Understanding of global regulatory process and being aware of all proposed changes that can affect the product responsible
- Very good written and spoken communication skills
- Good interpersonal skills in order to maintain good relationship with all teams responsible domestically and internationally
- Able to make decisions to positively impact all aspects of the regulatory process
- Be highly organised and ensure all deadlines are met while maintain high quality at all times
This is a contract role and to be considered candidates must be eligible to work in the UK. If successful you can expect a competitive salary package as well as the opportunity to join a world leader in global pharma.
Please contact Syeda Afsana Islam on 0161 942 4060 for more information on rates and applying.
Regulatory Site Officer – Contract – 12 Months - Suffolk