Regulatory Affairs Officer

Amazing Regulatory Affairs opportunity at one of the world’s largest healthcare companies!

They are looking for someone with profound post-market regulatory knowledge to join their regulatory submissions team as a Regulatory Affairs Officer.

The key responsibilities of the role include:

• Preparing and/or reviewing regulatory submissions to support clinical trial and marketing authorisation activities
• Preparation of submissions including: Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, and CMC authoring
• Managing day-to-day workload in collaboration with senior staff
• Preparing and/or reviewing regulatory documentation in area of expertise

We are looking to speak to any candidates that have:

• A bachelor’s degree in a life science field
• 5 years’ experience working within regulatory affairs
• Experience with lifecycle maintenance of products for Europe and/or emerging markets
• Experience with Marketing Authorisation Applications (MAA’s)
• Experience authoring CMC documents and variations

This regulatory submission’s role is an initial 12-month contract, which is paying an extremely competitive rate. The role is very flexible with their remote working requirements but to prefer some travel to the site in Reading.

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.

Clinical trial research

Market Authorisation Application (MAA)

Post market

Regulatory submissions

Regulatory Affairs

Life cycle maintenance