An autonomous Regulatory Affairs role - mentoring a small team.
An award winning, International, fast growth pharmaceutical business.
The key duties include:
Assist in the preparation and review of dossiers for MA applications (DCP, MR or national) and ensure timely submission of applications.
Assist in the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory submissions (DCP, MR or national) and ensure timely submission of applications
Assist in the preparation and review of responses to requests for further information from regulatory authorities
Prepare or review of national submission packages after the close of procedures
Liaise with regulatory authorities when required
Maintaining the product life cycle once the licence is approved.
Responsible for the product approval package review and maintenance.
Review of product information before product launch.
Liaising with internal and external contacts to ensure that dossiers are prepared following the current best practice standards.
To support the Regulatory Manager with SOPs, Change controls and review of internal processes.
The successful candidate will be a genuine self-starter with previous experience of Regulatory Affairs.
Experience of EU registration via DCP/MRP is essential, as is the ability to mentor more junior members of a small team.
A fantastic opportunity to join a growing business at a key phase of their development.
The opportunity to work with a Senior Director but to also manage your own work.
An opportunity to mentor a small team.
A competitive salary