Regulatory Affairs Specialist (m/f/x)
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals Limited.
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, maintain and expand the specified product registrations in the EU. Furthermore, the RA specialist will be responsible for keeping the products in compliance with all regulatory needs.
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have the following responsibilities:
- To organize submission of Marketing Authorisation variations applications for EU.
- 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 an application evaluation process to prepare and submit timely responses to Authorities comments and questions.
- 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.
- To provide support to Senior members for new Marketing Authorisations applications in EU territories and other relevant projects.
- To actively participate in Regulatory Intelligence activities and 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.).
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 veterinary medicine or other life sciences
- Fluent in written and oral English
- Good self-organisation skills.
- Ability to prioritize tasks based on the given deadlines
- Proficient computer skills
- Communication and presentation skills
- Experience in the animal health space or Regulatory Affairs 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
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