Regulatory Affairs Specialist (8 month FTC)
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 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.
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 the Regulatory Affairs Specialist will be to prepare, submit, and manage national phases for update of the SPC and Labelling text due to new Veterinary Regulation.
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- To ensure compliance of product literature (SPC, label, package leaflet) with latest requirements in the national and DCP/MRP procedures.
- To coordinate with National Competent Authorities (NCA) and relevant colleagues / partners during a variation application evaluation process to prepare and submit timely responses to Authorities comments and questions.
- QRD updates and related national phases to update SPC and Labelling texts due to new Veterinary Regulation.
- To liaise with RA EU Labelling group to co-ordinate new artwork production for product packaging according to regulatory legislation and Dechra packaging guidelines following approval.
- To update and maintain overview lists of activities as well as RA archives in order to properly report most recent status of given tasks.
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 degree preferably in life sciences
- Fluency in written and oral English
- Proficient computer skills
- Communication and presentation skills
- Problem solving skills
- Knowledge sharing skills
- Prior experience in RA or additional studies in relevant field would be advantageous
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 email@example.com
Dechra Pharmaceuticals PLC