Regulatory Affairs Officer
Salary: £45,000 – £55,000
This opportunity is for a Regulatory Affairs Officer who wants to be responsible for the preparation, distribution, and control of registration documentation for regulatory submissions in this £400m t/o global business. You will be making an active contribution to ensuring the company provides an uninterrupted supply of product to the market, in compliance with licensing particulars.
This opportunity will give you the chance to assist in the management of the team’s workload and personal development of staff. You will supervise and train other regulatory staff within department as required by the Head of Regulatory Affairs.
As well as this, you will be given the responsibility to perform the team management role in the absence of Regulatory Affairs Manager. You will be based in Felsted, Essex.
Some of the duties you will have the opportunity to be involved with are:
- Work proactively with team members of the local and cooperate business to ensure project needs are met;
- Contribute timely communication of safety information to regulatory authorities, healthcare professionals, and patients;
- Prepare or manage the preparation of marketing authorisation documentation to the highest standards;
- Provide input into plans for product development, commercialisation, discontinuation, or transfer at a local and cooperate level.
Within this PE backed business you will create and review local labelling, leaflets, and summary of characteristic documentation, ensuring compliance with current legislation for submission to the regulatory authorities. As well as this, you will monitor progress of submissions and organise deficiency responses to facilitate earliest approval.
For this role you will have:
- A degree in science;
- Proven experience in achieving regulatory approvals in the UK;
- Knowledge of development process for generic medicines, being capable of critically reviewing and integrating scientific information from a variety of disciplines;
- Self-motivated with the ability to demonstrate cross-functional collaborative working.