Regulatory Affairs Assistant

Job description

Job Description

Job purpose

The Regulatory Assistant is responsible for providing procedural support to all members of the Regulatory department. This will include managing local tracking databases, generating periodic reports, data entry into global databases, basic regulatory submissions and complaint sample shipping. The role also entails some administrative duties such as general filing, meetings and travel and budget support.

Key Responsibilities

• Develop in-depth (scientific and technical) product knowledge.
• General filing duties, stationary ordering and sorting of departmental post, assist with team travel arrangements, meeting organization and other administrative activities, raise and track purchase orders for all department activities, & log promotional copy review activities in local database.
• Submission of aggregate safety reports, Article 61(3) changes, Type IA and Type IB variations to MHRA/IMB, initiate post approval notifications and completion of associated activities & prepare Chemical and Pharmaceutical Datasheets and upload into global systems,
• Proof reading product information to ensure quality and accuracy & assist in product complaint sample management by co-ordinating shipping activities via DHL.
• Liaise with regulatory Health Authorities to clarify the status of regulatory submissions.

Desired profile

• Fluency in English. Any other European language would be an asset
• Experience in a similar role.
• Knowledge of regulatory requirements and guidelines for drugs and devices. Commercial awareness of the vision care market and or pharmaceutical industry; knowledge and understanding of products, services and marketplace - advantageous



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