Regulatory Affairs Manager
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
Available initially on a 12 month Fixed Term Contract – Remote Working Available!
As part of our continued growth, we have a brand new opportunity for an experienced Regulatory Affairs Manager to join our UK manufacturing team. This role can be performed remotely, although infrequent travel to our Skipton site would be required on occasion.
Reporting into the Head of Site Quality, the Regulatory Affairs Manager will have responsibilities for the regulatory activities involved in the Human Medicine Marketing Authorisation gap assessment and facilitation of improvement plan. In addition, the Regulatory Affairs Manager will be responsible for providing regulatory advice on potential remediation strategies and project management of the work stream
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Review of current approved Chemistry, Manufacturing, and Controls (Part II Quality) documentation against current manufacturing documents, identify gaps and improvement requirement
- Identify solutions for the gaps identified and prioritise the gaps based on risk management principles
- Generate appropriate variations document and work with cross-functional departments to generate data for variation submission
- Facilitate meetings with MA holders to address deviations and CAPA
- Liaise with relevant personnel and subject matter experts
- Report discrepancies/gaps in the appropriate form and present them to the project manager and/or remediation team as required
- Maintain regulatory files and spreadsheets relating to the project as required
- Provide regulatory advice on potential remediation strategies
- Provide second person review of the output of Project manager as required
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 here from those who have/are:
- Experience of UK/EU Human pharmaceutical Regulatory affairs
- Computer literate with a working knowledge of Microsoft Office (inc Word, Excel, Powerpoint and Outlook)
- Experience of registrations/maintenance of veterinary products would be an advantage
- 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
A degree level (or equivalent) qualification in Pharmacy, Biochemistry, Chemistry or similar scientific area is expected
Competitive + Benefits
12 month fixed term contract
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 email@example.com
Dechra Pharmaceuticals PLC