Principal Professional, Regulatory Affairs – Labelling

Vacancies

Principal Professional, Regulatory Affairs – Labelling

Job Introduction

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

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

Ensure Dechra meets the applicable regulations and accepted practices established by Local, Regional, and Federal Competent Authorities as they pertain to product / project assignments by providing awareness, assessment, and appropriate documentation as required for Labelling.

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:

• Lead and track all stages of label development.
• Coordination or oversight of activities related to annotations, label artwork creation, and revision activities between key stakeholders including regional artwork coordinators, Internal Graphics Design Team, Regulatory Affairs, Quality, Marketing, Product Development and internal and external Manufacturing organizations.
• Compile all necessary contributing content and parameters needed for artwork development and submissions.
• Proofread and review revised artwork prior to submission and/or release for production or marketing purposes.
• Prepare labelling submissions and liaise with FDA as needed.
• Serve as subject matter expert (SME) regarding labelling guidance and strategies.
• Initiate new labelling artwork or revision to existing labelling artwork for assigned products.
• Monitor new applicable FDA regulations, guidance documents and compliance policies as they apply to animal health products.
• Assist with implementation and adoption of new processes, procedures, systems and software.
• Review and approval of Advertising and Promotional Materials.

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:

Education and Experience

• 5+ years in a pharmaceutical regulatory affairs or quality environment, with specific experience in US labelling requirements.
• Experience within a US-regulated environment, preferably in the animal health pharmaceutical industry.
• Awareness of regulatory requirements for generic product labelling, innovator product labelling, and distributor labelling.

Skills and Competencies

• Exceptional attention to detail.
• Exceptional proofreading skills.
• Effective listening, verbal, and written communication skills.
• Excellent interpersonal skills, with the ability to communicate effectively with all levels and establish and maintain effective working relationships.
• Strong leadership qualities.

Abilities

• Ability to plan, organize, and prioritize workload to meet deadlines.
• Ability to keep several projects moving forward simultaneously.
• Ability to be flexible due to frequent shifts in priorities.
• Self-starter with the ability to demonstrate a methodical, organized, and flexible approach to work.
• Able to work independently with minimal supervision.

Desirable

• SME status in veterinary pharmaceutical labelling.
• Artwork management software including electronic approval workflows.
• Prior experience with Advertising and Promotional material review.
• Prior experience with Health and Wellness products or NASC.
• Prior experience in Animal Health Industry.
• Knowledge of Regulatory CMC or Safety and Efficacy