Regulatory Affairs Associate - 12 month FTC
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.
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 over 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.
Job Purpose
Regulatory Affairs (RA) Associate within the RA EU coordination team is responsible for administering the RA inbox, compiling administrative requirements for submissions, invoice coding, sales figure reporting, archiving, etc. RA Associate is also updating and maintaining regulatory activities in the Regulatory Information Management System, creating electronic submission based on available dossiers and supporting registration procedures. RA Associate performs submissions under supervision of a more senior team member.
Role Responsibility
- Assist RA colleagues with overview lists, cost estimates and other analysis etc.
- Administer Regulatory email inbox and archive
- Update and maintain the regulatory Information Management System with the support from RA and PD colleagues
- Ensure received invoices for RA are coded, approved and sent back to finance for payment in due course. Archive and keep an overview of paid invoices
- Compile sales figures and reporting to Agencies as needed
- Compile and submit electronic submission for new submissions and variations based on prepared dossiers for EU territories under supervision of a more senior team member
- Following approval of a submission ensure Marketing Authorisation is checked, that all documentation is archived according to agreed procedure and relevant documents/databases are updated. Finally ensure distribution of Marketing Authorisation information to all relevant colleagues.
- Support RA colleagues with requesting various needed certificates and samples
The Ideal Candidate
- Experience within Regulatory Affairs
- 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. Fluent in spoken and written English.
- 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
- Computer literate with a working knowledge of Microsoft Office (including Word, Excel, and Outlook)
- Practical experience of working in a busy working office environment
Desirable:
- Experience in pharmaceutical industry
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 recruituk@dechra.com