Regulatory Affairs Manager
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 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
Flexible Location: UK Remote, Hybrid or Office Based from our site in Shrewsbury
The Opportunity
A unique opportunity has arisen for an experienced Regulatory Affairs Manager to join our UK Regulatory Affairs Team. The successful candidate will have responsibilities for the preparation, submission, maintenance and expansion of the specified product registrations in specified countries
The Regulatory Affairs Manager will work to provide technical regulatory support to product development project teams and negotiate and advise on the clinical program with the regulatory agencies in order to identify clear risk assessed routes to Marketing Authorisation approval
The successful candidate will also be tasked with leading and managing the Sansaw based Artwork team.
Role Responsibility
The Challenge
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Design of registration operating plans to ensure senior management objectives are achieved
- Provide regulatory technical and strategic guidance to the product development teams to ensure any proposed studies are prepared to meet guidelines and support product registrations
- Prepare and submit variations and renewal applications for existing products to ensure existing dossiers reflect current practice
- Prepare EU regulatory submissions. Project manage the procedure from development, initial preparation of the dossier to approval and launch
- Responsible for leadership, management of the artwork team to co-ordinate new artwork production for product packaging according to regulatory legislation and Dechra packaging guidelines
The Ideal Candidate
About You
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:
- Previously experience working in Regulatory Affairs capacity within Pharmaceuticals
- Previous Regulatory leadership experience is highly desirable
- Experience setting up and maintaining manual and electronic filing systems
- Excellent interpersonal skills, with the ability to communicate effectively with all levels, establishing and maintaining effective working relationships
- A Veterinary or Life Sciences degree or similar level qualification is desirable
- Ability to demonstrate a methodical, organised and flexible approach to work, both personally and with colleagues
About the Company
About Your Application
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
Dechra Pharmaceuticals PLC