I am currently recruiting for a Regulatory Specialist / Manager to join an exciting company based in Berkshire. Within this role you will work with the Head of R&D, to organise and manage the Regulatory Affairs function. This will include responsibility for performing, reviewing and approving regulatory affairs activities, including the application for New Product Registrations (MAAs), maintenance of existing Product Registrations (Variations and Renewals).
* Management of Regulatory project work/project lead.
* Preparation and coordination or review of documentation or dossiers.
* Regulatory strategy (pre-submission or post-approval stages)
* Maintaining an awareness of the EU Regulatory landscape (Pharmaceutical & Device) and changing regulatory requirements
* Preparation and project management of Pharmaceutical Marketing Authorisation Applications (MAA) & Medical devices (STED)
* Artwork management on medical devices and pharmaceutical products.
* Preparation and review of responses to questions
* Preparation and review of post-approval/Variation and Maintenance submissions
* Dossier reviews and gap analyses
* Interact and negotiate directly with regulatory authorities and notified bodies. Assisting with Scientific Advice procedures
Knowledge and Experience:
* Proven experience in a similar Regulatory Affairs role working with pharmaceuticals/medical devices with knowledge of the Medical Device Directive (MDD), Medical Devices Regulation (MDR),
* Ideal candidate would have around 5 years' experience in Full lifecycle regulatory affairs within Pharmaceutical and or medical devices.
* Experience in developing regulatory affairs strategy, and interpreting, implementing and communicating regulatory changes, and developing team members.
* Knowledge of US and international medical device regulatory requirements, procedures, regulations
For further information, please contact Tim Barratt on (phone number removed) or email (url removed)
Medical Device Directive