Regulatory Affairs Associate
12 Month initial contract - view to extend
Weybridge, Surrey - Hybrid working from home
Pay rate up to £41 per hour via Umbrella inside IR35
• As Regulatory Affairs Associate you will be responsible for the execution of regulatory activities related to development and life-cycle maintenance (including dossier management) for a defined portfolio of consumer products
• Manage updates and coordination of product dossiers, including cosmetic PIFs, medical device technical files, and TMACs
• Interacts with colleagues in other global functions (e.g. Global Development Operations, Supply Chain, Toxicology) and Regulatory Affairs sub-functions to deliver high quality dossiers, documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruence and regulatory compliance.
• Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
• Provides evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records e.g. change controls
• Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends.
We are looking for professionals with these required skills to achieve our goals:
• Degree in a life science or equivalent regulatory experience
• At least 1 year regulatory experience of Cosmetics and/or Medical Devices
• Good communication Skills – Oral and Written
• Good organisational Skills
• Masters or Doctorate level education
• Preferably 2-3 years regulatory affairs experience, including experience of the Oral Care sector
• Experience of working on regulatory information in a database / vault format
• Some knowledge of the Medical Device Regulation (MDR)
• Be able to provide an assessment of the regulatory impact of potentially complex / multiple changes impacting a portfolio of products in parallel