Job title: Senior Regulatory Affairs Executive UK/IE
A global pharmaceutical company with an office in Central London are seeking a Senior Regulatory Affairs Executive. This role will be responsible for maintaining existing, and obtaining new, marketing authorisations in UK and Ireland for national, MRP, DCP and Centralised products. You will have the opportunity to work across exciting therapy areas such as Oncology, Gastroenterology and Diabetes. This role is office-based 2 days per week.
- Maintain existing, and obtain new, marketing authorisations in UK and Ireland for national, MRP, DCP and Centralised products
- Ensure that the necessary regulatory support is provided to local, regional and global regulatory affairs functions and collaborate fully with other local and global functions including commercial teams.
- Prepare, compile and submit a range of regulatory applications for national, MRP and DCP products, including: Type I and Type II variations, Article 61(3) Leaflet and labelling changes, Change of ownership applications, Renewals and PSURs
- Educated to at least degree level in a scientific discipline.
- At least 3 years' experience within a regulatory affairs role within the pharmaceutical industry.
- Knowledge of national, MRP and DCP & Centralised procedures in the UK and/or Ireland.
- Experience of preparing and submitting post-marketing regulatory applications to the MHRA and HPRA (i.e. variations, renewals, post-marketing commitment submissions, PSURs and other ad hoc activities as required)
Salary and benefits:
A highly competitive salary, annual bonus and wider benefits package is on offer
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org