Regulatory Affairs Scientific Leader
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
The Opportunity
Flexible Location!
**This role can be based anywhere in the UK and can be performed remotely or from our offices in Sansaw, Shrewsbury or a hybrid of remote and office working.**
We have a new opportunity within our Product Development & Regulatory Affairs (PDRA) division for an experienced Regulatory Affairs Scientific Leader to join our growing global family of employees. Reporting to the Senior Regulatory Affairs Manager, the successful candidate will have responsibilities for preparation, submission, maintenance and expansion of the specified product registrations in specified countries
The Regulatory Affairs Scientific Leader will support product development project teams and negotiate on the clinical program with the regulatory agencies in order to identify clear routes to Marketing Authorisation approval.
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 guidance to the product development teams to ensure any proposed studies are prepared to meet guidelines and support product registrations
- Liaison with manufacturers to prepare Part II (Chemistry and Manufacturing) of new drug submissions for Veterinary Medicinal Products
- Prepare and submit manufacturing variations and renewal applications for existing products to ensure existing dossiers reflect current practice
- Prepare EU regulatory submissions. Project manage the procedure from initial preparation to approval
- Prepare and maintain product summaries for pharmaceutical products
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:
- Previous experience within a Pharmaceutical organisation in a similar capacity
- Educated to degree level (or equivalent) in a related scientific discipline
- Computer literate with a working knowledge of Microsoft Office (including Word, Excel, and Outlook)
- Experience of working as part of a team and on own initiative
- Experience of responding to queries and simple problem solving
- Setting up and maintaining manual and electronic filing systems
- Practical experience of working in a busy working office environment
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