Regulatory Affairs Professional

2 weeks ago

Shrewsbury Shropshire, United Kingdom Dechra Full time
Summary

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide. Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, ( D )edication, ( E )njoyment, ( C )ourage, ( H )onesty, ( R )elationships and ( A )mbition are at the heart of our everyday operations and the way we do business. The Opportunity The primary purpose of the Regulatory Affairs Professional will be to prepare, submit, maintain and expand the specified product registrations in specified countries. Furthermore, the RA Professional will be responsible for keeping the products in compliance with all regulatory needs.

Main Responsibilities

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including: Preparation and compilation of registration dossiers in accordance with UK and EU legislation. To organise submission of Marketing Authorisation variations and re-registration applications for UK and the EU. To coordinate with National Competent Authorities (NCA) and relevant colleagues / partners during an application evaluation process to ensure, prepare and submit timely responses to Authorities comments and questions. Where applicable, to obtain national phase registration. To liaise with Artwork Coordinators to co-ordinate new artwork production for product packaging according to regulatory legislation and Dechra packaging guidelines following approval. Active cooperation with other departments in the company. To constantly monitor changes in legislation/guidelines to ensure all submissions are submitted to the latest requirements; To cooperate and maintain contact with national authorities and industry organisations (working groups, info days etc.). Prepare and regular check Quality Product Compliance Summaries for pharmaceutical products. Archiving of registration documentation.

Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly keen to hear from those who have/are: University or bachelor's degree in chemistry, chemical engineering, veterinary medicine, pharmaceutics, biochemistry, or related disciplines A minimum of 3 years regulatory affairs experience Fluency in written and oral English Proficient computer skills Communication and presentation skills Problem solving skills Desirable Experience of regulatory affairs within an animal health company

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