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Senior Regulatory Affairs Scientist / Regulatory Affairs Professional

Please Note: The application deadline for this job has now passed.

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.

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 colleague 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 

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high-quality products exclusively for veterinarians worldwide.  The primary purpose of this position is to prepare, submit, maintain and expand the specified product registrations in specified countries and to assist in the registration of new veterinary medicinal products in International markets. Furthermore, the successful candidate will be responsible for keeping the products in compliance with all regulatory needs.

Role Responsibility

So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:

  • Compiling, reviewing and submitting new Marketing Authorisation applications in International territories.
  • To organize submission of Marketing Authorisation variations and renewal/re-registration applications (where relevant) for International markets.
  • To coordinate with National Competent Authorities (NCA) and relevant colleagues / partners during an application evaluation process to, prepare and submit timely responses to Authorities comments and questions.
  • To liaise with Artwork Coordinators in UK, NL and HR to co-ordinate new artwork production for product packaging according to regulatory legislation and Dechra packaging guidelines following approval.
  • Prepare and regular check Quality Product Compliance Summaries for pharmaceutical products.
  • To constantly monitor changes in legislation/guidelines to ensure all submissions are submitted to the latest requirements.
  • Efficient and accurate assembling of data for submissions.
  • Delivery of prioritised registrations and maintenance work in International markets.
  • Relationship building with key colleagues to ensure information required for making artwork changes is obtained and important information is passed to the relevant people in the process.
  • Achieve full Regulatory Information Management System (RIMS) use in prescribed time frames.
  • Archiving of registration documentation.

The 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 degree in chemistry, chemical engineering, medicine, pharmaceutics biochemistry, or related disciplines
  • Fluency in written and oral English
  • Proficient computer skills
  • Communication and presentation skills
  • Problem solving skills
  • Knowledge sharing skills 

About the Company

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 Pharmaceuticals PLC in Croatia is Genera Inc.  

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

Dechra Pharmaceuticals PLC

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