The Role:The Regulatory Affairs Executive is responsible for preparing high quality documentation for regulatory submissions; liaising with relevant departments to ensure regulatory requirements for these...
The Regulatory Affairs Executive is responsible for preparing high quality documentation for regulatory submissions; liaising with relevant departments to ensure regulatory requirements for these submissions are met; proactively communicating with regulatory authorities in order to expedite approval of these submissions.
- To prepare and submit high quality documentation for all regulatory submissions, following current best practice standards
- To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities in order to expedite approval of submissions
- To prepare and maintain product labelling for appropriate markets in cooperation with local regulatory and commercial contacts
- To anticipate and resolve simple regulatory issues
- To actively participate as primary regulatory resource in cross-functional project teams
- To prepare and review plans for submissions within agreed timelines and ensuring alignment with agreed strategy
- To identify and provide information for incorporation in the Regulatory databases as appropriate
- To provide information on expenditure against budget for inclusion in periodic financial reports
- To maintain the paper and electronic filing systems for assigned products/countries, following Records Retention procedures
Experience / Qualifications
- Life Science Degree Qualified
- Hands on regulatory experience and general knowledge of worldwide and particularly UK and Ireland, regulatory requirements.
- A full strategic understanding of the drug development principles and processes
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.