Regulatory Affairs Administrator
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
Regulatory Affairs Administrator within the RA EU Labelling team is responsible for coordination of artwork preparation using the artwork change implementation software system ‘Twona’ and for release of artwork to Manufacturing. This is done in close cooperation with the other RA labelling colleagues, the Dechra graphic group and with other Regulatory Affairs collegues involved in the process. Furthermore the RA Administrator - RA EU Labelling is supporting preparation of SPC and labelling text (Quality Review of Documents (QRD).
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Work as part of a EU Labelling team, The RA Graphic Team and wider Regulatory Affairs Team.
- Provide support for the translation of SPC and labelling text
- Obtain item codes, artwork item codes and GTIN numbers for artwork.
- Request new/amended artwork in artwork system Twona for all markets (in connection with re-registration, variations, new markets, etc.).
- Ensure appropriate approval and sign off of new/amended artwork and liaise with manufacturers regarding release of final artwork.
- Ensure new packaging artwork is implemented within the required regulatory timeframe, and to meet manufacturing deadlines.
- Maintenance of electronic and paper documentation/records.
- Knowledge of legislation within packaging material for EU in respect to batch/expiry, font size, production requirements, etc.
- Assist RA colleagues with overview lists, cost estimates 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:
- Ability to demonstrate a methodical, organised and flexible approach to work
- High level of attention to detail and ability to follow detailed procedures and processes
- Effective listening, verbal and written communication skills
Excellent interpersonal skills, with the ability to communicate effectively with all levels, establishing and maintaining effective working relationships.
Ability to plan, organise and prioritise workload to meet deadlines
Ability to maintain a high level of confidentiality and discretion at all times
Experienced user of Microsoft Office programs
Fluent in spoken and written English
Computer literate with a working knowledge of Microsoft Office (including Word, Excel, and Outlook)
Setting up and maintaining manual and electronic filing systems
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 firstname.lastname@example.org
Dechra Pharmaceuticals PLC