Regulatory Affairs Officer

Exciting Regulatory Affairs opportunity at one of the world’s leading healthcare companies!

They are looking someone with profound regulatory knowledge to join their submissions team as Regulatory Affairs Officer!

The key responsibilities of this role include:

• Preparation of submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, CMC authoring and \ or updates as required.
• Manages day-to-day workload in collaboration with senior staff, as appropriate.
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.

We’re looking to speak with any candidates that have:

• Good post approval experience
• 3+ years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)
• MA transfers experience in an advantage
• Degree in life science field

This regulatory role is an initial 6-month contract with the potential for extension. The regulatory submission’s role is paying competitive rate and 100% remote based, so your location within the UK is not an issue.

If this sounds like the ideal role for you, please send your CV to bshepherd@aerotek.co.uk. If this does not sound like the right role for you but you know someone that could be right, please forward on a method of contact to this person and you could be eligible of a referral fee. Also, we have a variety of roles that could be of interest but might not be advertised due to NDAs so please do feel free to send over your profile and we will be in touch with relevant positions.