Regulatory Affairs Specialist

Overview

Talent Mark is recruiting for a Regulatory Affairs Specialist to join a company in the Pharmaceutical industry, at their site based in Reading, on a contract basis initially for 4 to 6 months.

£50.75 per hour PAYE or £68.89 per hour Umbrella (inside IR35)

• Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan.
• Manages the coordination, compilation, submission of new drug applications, cosmetics, medical devices, and food supplements.
• Assesses the acceptability of quality, preclinical and clinical documentation for submission filing.
• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.

• Hold a relevant scientific degree or have equivalent working experience.
• Experience with local UK/IE affiliates, direct engagement with authority MHRA and HPRA.
• Knowledge of OTC medicines, plus experience with post‑approval activities for both safety & CMC.
• Exposure to PAGB is a plus.
• Extensive experience in regulatory affairs in pharma, consumer health, or similar.

Our client is the largest and most broadly‑based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

This role can be remote based in the UK, preference for 2 days per week onsite in Reading.

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only).

Please note:

This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.

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