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

• To assist labeling coordinators with all aspects of label development and implementation
• To assure the product regulatory history and correspondence files are maintained and accessible.
• To assist state licensing manager with completion of application tasks assigned.
• To complete assigned annual reports and administrative operational tasks as assigned.

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:

• Assist with maintaining the logs and indexes of labelling projects, regulatory communications, and state licenses as assigned
• Assist with initiation of new labelling or revision to existing labelling components (printed labelling) for assigned products.
• Coordinate and carry out label creation, revision, and implementation activities with the UK Graphics Design Team and the Manufacturers as assigned.
• Demonstrate an awareness of FDA regulations, guidance documents and compliance policies.
• Complete annual Drug Experience Report for assigned product(s).
• Assist with completion of state license application(s) as assigned.
• Manage FDA filing for assigned products (activities)
• Coordinate translations with vendors as assigned
• Support of other administrative tasks as needed

Key Performance Indicators

• Development of strong relationships with the key stakeholders in labeling, manufacturing, supply chain, finance, and product development.
• Earn the confidence of regulatory affairs team members through consistent reliable delivery of assigned tasks and key responsibilities.
• Delivery of assigned outputs (labels, license applications, annual reports) to relevant stakeholders within agreed timeframes.

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:

• 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 
• Ability to plan, organize and prioritize workload to meet deadlines 
• Ability to keep several projects moving forward at the same time 
• Ability to be flexible due to frequent shifts in priorities
• Ability to complete and prioritize tasks assigned by various team members
• 2-4 years in a pharmaceutical regulatory affairs or quality environment
• Awareness of regulatory requirements for generic or innovator products

Desirable Knowledge and Experience:

• Specific experience in label coordination, state licensing, drug listing, or annual reporting.
• Experience with print vendors and graphics terminology
• Experience with Adobe Acrobat Pro 
• Experience with Artwork Comparison tools
• Experience with Apostille process.

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