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Regulatory Affairs Sr. Specialist - Labeling

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

The Opportunity 

To coordinate labeling projects and manage activities across functional groups (i.e., RA, QA, Marketing, Legal, and Manufacturing) to facilitate the development, finalization and implementation of new or revised product labeling for assigned products.

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:

  • Track all stages of label development and implementation.
  • Compile all necessary contributing content and parameters needed for artwork development.  
  • Annotate artwork changes and coordinate revisions with Graphic Art Team.
  • Proofread and review revised artwork prior to submission or release for production or marketing purposes.
  • Maintaining the current status log of all labeling projects and update regulatory management database as assigned.
  • Initiate new labeling artwork or revision to existing labeling artwork for assigned products.
  • Increasing awareness of FDA regulations, guidance documents and compliance policies as they apply to animal health products.
  • Coordination or oversite of activities related to annotations, label artwork creation, revision, and implementation activities between key stakeholders including regional artwork coordinators, Internal Graphics Design Team, Regulatory Affairs, Marketing, Product Development and internal and external Manufacturing organizations.
  • Assist with implementation and adoption of new processes, procedures, systems and software.
  • Subject matter expert on TVT Comparator.
  • Familiar with outputs of Illustrator, In Design, and Acrobat software used in labeling artwork creation.
  • Development of strong relationships with the Graphics Design Team, graphic and print vendors, Manufacturers and other internal stakeholders.

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
  • Exceptional proofreading skills
  • 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 Able to work independently with minimal supervision.
  • Awareness of regulatory requirements for generic or innovator product labeling Experience with Adobe Acrobat Pro.

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

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