Regulatory Affairs Officer

Salary: £54 – £66 per hour

Do you want to be part of a fast-growing, globally recognised Scientific and Regulatory company?
If you do, we want to hear from you as we have an exciting Regulatory Affairs Officer within our growing Regulatory team.
Broughton Nicotine Services are a consultancy service providing analytical, scientific and regulatory support to businesses in the e-cigarettes, alternative nicotine products and nicotine-containing pharmaceutical products enabling them to increase the value of their business and advance a smoke-free future.
The Regulatory Affairs team is a group of experienced subject matter consultants that offer regulatory expertise across the full product life-cycle i.e. regulatory strategy/pathways, dossier compilation/submission and post-submission maintenance
The role of the Regulatory Affairs Officer is to contribute to high-quality regulatory submissions (eCTD, TPD, PMTA, Medical Devices) to global health authorities aligned with all applicable standards.
Main Purpose of job
The main purpose of the role as a Regulatory Affairs Officer is to assist in the preparation and review of high-quality regulatory documents for global submissions. You will help collect, collate, evaluate and compile scientific data from a range of sources into submission-ready packages whilst providing on-going regulatory advice to project teams.
As a Regulatory Affairs Officer you will ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
Within the role of Regulatory Affairs Officer, you will provide regulatory support to internal departments and external clients (experience dependent) and provide format and content review of all regulatory documentation e.g. CTD Modules, packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling. This role will ensure all Internal Tracking Tools, Electronic Databases and Filing Structures are Maintained, Accurate and Complete.
Key person specification
* Pharmacy, Biological or Chemical Science degree
* Previous experience (2 to 5 years) in a pharmaceutical or medical device regulatory affairs role is required.
* Hands-on experience in the compilation, review or publishing of technical sections of Marketing Authorisations (i.e. Module 3, 4 or 5 plus overall summaries)
* Exposure to ENDS, TPD and/or PMTA would be desirable.
* Ability to work across multiple work-streams.
* Excellent communication skills, written and verbal.