Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.

Dechra is 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

Job Purpose

• Lead labeling artwork development and revisions for products including innovator and generic veterinary drugs and veterinary health and wellness products.
• Liaise with other Regulatory Affairs team members and cross-functional teams to ensure the accuracy of information included in all labeling components.
• Coordinate with Regulatory Affairs Management, Product Development, and Marketing to align proposals for labeling strategies and deliver labeling strategies.

Role Responsibility

So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:

• Drive development of an aligned global regulatory procedure.  Coordinate a global Kaizen Event to include key stakeholders
• Implement process improvements defined in the Kaizen Event for approved products and conduct feedback / review sessions
• Transition coordination of Care product / Health and Wellness products labels into global artwork program.
• Coordinate label development, revision, and implementation activities with internal and external stakeholders.
• Prioritize, organize and track progress for multiple simultaneous labeling projects.
• Coordinate with other Regulatory team members for development, review, preparation and submission of FDA labeling supplements.
• Review new labeling for accuracy and compliance with regulatory requirements.
• Liaise with internal and external manufacturers to assure labeling is acceptable for use with manufacturing equipment and processes.
• Assess changes in FDA requirements to identify impact to product labels.
• Monitor changes to Referenced Listed New Animal Drug (RLNAD) product labeling for generic products.
• Notify commercial and support teams of updates to approved labeling or implementation of new labeling.
• Develop and maintain tools/lists that help assure version control. 
• Maintain, catalog, and make available all current labeling materials in accordance with company policies, procedures and technologies to assure availability of labeling materials across functions, i.e, QA, advertising, annual reporting, supply chain, etc
• Coordinate with other functions (eg: Quality, manufacturing) to help assure that labeling released to the market is consistent with labeling on file with the regulatory authority..
• Trigger and confirm completion of electronic drug listing with other RA team members for revised or new labels.

Key Performance Indicators

• Development of strong relationships with the Graphics Design Team (or external graphics vendors), Manufacturers, Marketing, Supply Chain, Quality, Veterinary Technical Services and other stakeholders
• Delivery of labels to relevant stakeholders within agreed timeframes
• Identify and implement solutions for areas of process improvement

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 excited to hear from those who have/are:

Skills-Essential

• Strong regulatory labeling operations experience including an understanding of 21 CFR labeling requirements.
• Exceptional attention to detail
• Self-starter with ability to demonstrate a methodical, organized and flexible approach to work
• 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
• Able to plan, organize and prioritize multiple priorities and issues to meet deadlines
• Ability to keep several projects moving forward at the same time
• Creative problem solving approach

Skills-Desirable

• Drug Listing – SPL
• Familiarity with graphics arts or label creation software
• Familiarity with labeling regulations and labeling operations for products in the other major global regions, i.e, EU, UK.

Qualifications-Essential

• Bachelor Degree with 3-5 years’ experience with label coordination in a regulated environment, preferably for veterinary pharmaceutical products.
• Sixth Sigma Training - Green Belt
• Excellent command of English grammar, spelling and punctuation.
• Good understanding of pharmaceutical or medical terminology
• Understanding of pharmaceutical business functions that impact labeling
• Excellent organizational skills

Qualifications-Desirable

• Experience interacting with FDA Center for Veterinary Medicine, MHRA, VMD, or EMA

Knowledge and Experience-Essential

• Understanding of FDA guidances and regulations pertaining to labelling for generic and innovator products
• Experience with Adobe Acrobat Pro
• Experience with Artwork Comparison tools
• Experience with process improvement activities and tools

Knowledge and Experience-Desirable

• Experience with Adobe Acrobat Pro
• Experience with Artwork Comparison tools
• Experience with process improvement activities and tools

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an employee stock purchase plan for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.

Dechra Pharmaceuticals PLC