Regulatory Affairs (Global Submissions CTA/MAA)

Advanced Resource Managers are looking for a Regulatory Affairs Manager to join their client who are a leading Clinical Research Organisation. You will be working on a client dedicated sponsor who have products within the Oncology and rare disease space.

This position will see you as an integral team member of the team,  therefore you will need strong experience within regulatory affairs as you will be responsible for driving submissions including CTAs and MAAs on a global level.

You will need to be confident in providing regulatory advice and carry out projects in the provision of regulatory affairs services and be able to offer guidance to improve CTA submission to other less experienced team members.

Experience Requirements:

•    Experienced regulatory background in clinical research and drug development
•    Project management experience and experience successfully building relationships across a diverse stakeholder team
•    Experience with global CTA and MAA submissions


Knowledge, Skills and Abilities:

•    Good interpersonal skills
•    Effective oral and written communication skills
•    Good organizational and planning skills
•    Ability to work on own initiative
•    Ability to motivate and integrate teams and teach/mentor team members

•    Good knowledge of global / regional / national country requirements /

This is a permanent full time position which will be fully remote home based. As part of this role, there will be some travel needed post Covid to the sponsor sitebut this will be minimal and you can be based in any European Country. My client are offering a salary of €62,000 - €73.119 plus package.

This is an urgent requirement, if you are interested in hearing more please email me on Vik.patel@arm.co.uk