Your newpany
An established, research-driven generics pharmaceuticalpany with a strong presence across the UK and EU markets. The organisation offers a collaborative, team-oriented environment and ismitted to delivering high-quality, affordable medicines while supporting employee development.
Your new role
As a Senior Regulatory Affairs Associate, you will support the lifecycle management of a diverse portfolio of generic medicinal products. You will be responsible for preparing and submitting regulatory dossiers (including MAAs, variations, and renewals) in line with MHRA and EMA requirements, as well as managing post-approval activities.You will liaise with regulatory authorities, respond to queries within agreed timelines, and ensurepliance of product labelling and documentation (SmPCs, PILs, artwork). The role also involves supporting regulatory strategy, tracking submission timelines, and monitoring evolving regulatory guidelines to assess business impact.
What you...