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European Regulatory Affairs Officer - Essex - Permanent, Essex



Essex, United Kingdom 

Job Category:



€42,000.00 - €45,000.00

EU work permit required:


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Job Description:

Perform the necessary regulatory tasks to help obtain the authorities clearance to market non-medicinal products (i.e. notification, registration, etc.) in EMEA and in other global countries in collaboration with regional and local RA units. Ensure high quality data and standards are used in support of all regulatory applications to achieve rapid and successful assessment. Lead the registration process for non-medicinal products. Co-ordinate the preparation and conduct the review of responses to questions raised by the authorities. Give regulatory support to project teams, stakeholders and customers, as required. Assist to Sr Manager of non-medicines in development of registration strategies. Assist to Sr Manager of non-medicines in development/strengthening of processes (SOPs, WIs) Work effectively with stakeholders to ensure that local regulatory needs are understood and incorporated into regulatory input and strategies for initiatives. Develop and maintain thorough and up-to-date understanding of the EMEA regulatory environment: provide early input to multifunctional team on Global R&D initiatives and plans. Ensure full compliance of all marketed products and marketing/sales activities with national regulatory requirements including but not limited to packaging and communications, and import/export procedures. To apply or for more detail please call Emma +44 1727 817646 OR email erussell@keypeople.co.uk

Job Requirements:

Medicine/Veterinary/Sciences/ Science degree, with pharmacy qualifications a plus Good knowledge of pharmaceutical & scientific processes Three or more years of regulatory experience Experience in registration of medicinal products in the EMEA and other international markets Knowledge in registration process and assessment of non-medicinal products Regulatory experience in non-medicine legislation, regulatory procedures and requirements Knowledge of clinical development, pharmacovigilance and life cycle management. To apply or for more information please call Emma +44 1727 817646 OR email erussell@keypeople.co.uk
Company Info
Key People
Catherine House
St Albans, United Kingdom
Phone: 441727811634
Web Site: www.keypeople.co.uk
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