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 

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales and marketing of high-quality products exclusively for veterinarians worldwide. 

As part of our continued global growth, we have an exciting new opportunity for a Head of Regulatory Affairs – Netherlands. This role can be located remotely, anywhere within Europe and will have requirements to travel both domestically and across continental Europe where required.

An exciting opportunity has presented for a Head of Regulatory Affairs (UK&NI) to join our growing global PDRA business unit. The primary responsibilities of the Head of Regulatory Affairs will be to lead a subgroup of the RA team in the UK and participate in growing the EU RA team, delivering its strategic goals and driving technical excellence.

The successful candidate will also be responsible for preparation, submission, maintenance and expansion of the specified product registrations in specified countries and to support product development project teams. The Head of Regulatory Affairs will also be expected to negotiate on the pharmaceutical / 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:

• Provide team leadership, coaching and technical expertise in EU regulatory affairs
• Oversight of the centralised artwork team
• Work as part of cross functional Product Development teams, so develop new veterinary medicines, and to create extensions / variations to existing ones.
• Contribute to scientific study design, dossier compilation, responses to questions.
• Manage Regulatory submissions through National and European Agencies. Partner with US colleagues on parallel global procedures.
• Drive compliance and business improvements ensuring all activities are captured in Regulatory Information Management System (RIMS) and documentation filed according to Dechra procedures
• Oversee RA evaluation of change controls and prepare and submit variations applications for existing products to ensure existing dossiers reflect current practice
• Oversee post authorisation surveillance activities and provide coaching, mentoring and leadership at the EU level in this area.
• Ensure that product summaries for pharmaceutical products are prepared for new products and evaluated once a year (on request from QA)
• Ensure that management are kept informed of key issues and achievements

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:

• Significant EU pharmaceutical regulatory affairs experience
• Experience working within the Animal Health industry is highly desirable
• Previous experience managing remote workers
• Excellent communication and presentation skills
• Previous experience in the preparation, submission, maintenance and expansion of product registrations
• RCVS qualification is desirable
• A Bachelor degree in chemistry, chemical engineering, veterinary medicine, pharmaceuticals, biochemistry, or other related discipline

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