Regulatory Affairs Associate

Job Introduction

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 3000 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

Regulatory Affairs Associate in RA EU Clinical team has responsibilities for assisting more senior personnel in preparation,submission and maintenance of RA documentation in Europe.

This role covers internal and external system maintenance as well as any other support activity in product life cycle of Dechra portfolio in EU/UK.

Regulatory Affairs Associate works under supervision to deliver longer-term regulatory tasks with low complexity and departmental impact.RA associate applies basic regulatory knowledge,demonstrates personal initiative, and contributes effectively to the immediate team while starting to develop their skills and expertise.

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:

Financial: Preparation and maintenance of overviews, cost estimates, arranging submission pre-payments.
Submission activities: Compile electronic submissions for new applications, and variations based on prepared dossiers for EU territories, through relevant electronic portals (CESP, UPD, VMD, Iris, etc), informing Stakeholders of the submission status.
Submissions: Support role for new Marketing Authorisation applications or variations for EU territories, ensuring compliance with regulatory requirements.
Systems support: update Regulatory Information Management System (Veeva) to ensure status is current and accurate.
Assist stakeholders during the application evaluation process to ensure timely preparation and submission of responses to authorities' comments and questions.
Update and maintain overview lists of activities to ensure accurate tracking and reporting. 
Continuously monitor changes in legislation and guidelines and ensure stakeholders are notified of changes (Via webinars and training).
Perform other regulatory affairs tasks as assigned by direct management, supporting team objectives and departmental need.

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:

Fluency in written and oral English
Proficient computer skills
Communication and presentation skills
Problem solving skills and knowledge sharing skills
ISCED Level 3 (Gymnasium) or High school degree/Bachelor’s in office management, administration (or similar), pharmacy, chemistry, chemical engineering, agronomy or related disciplines
Willing to work as the office based worker

All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at recruituk@dechra.com

The legal employer on behalf of Dechra in Croatia is Genera Inc.

Genera Inc. is a part of the Dechra Group since 2015

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