Senior Professional Regulatory Affairs - Ad and Promo

About the role

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 promotional review.

Responsibilities

• Review and approval of Advertising and Promotional Materials.
• Creation of ISI and Brief Summary Documentation.
• Prepare and submit submissions and liaise with FDA as needed.
• Serve as subject matter expert (SME) regarding promotional guidance and strategies.
• 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.
• Partner with Commercial stakeholders to support company goals.
• Support some labelling activities as required.

Requirements

• Prior experience with Advertising and Promotional material review.
• Exceptional attention to detail.
• Self-starter with ability to demonstrate a methodical, organised, 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.
• Strong leadership qualities.
• Ability to plan, organise, and prioritise workload to meet deadlines.

Desirable Qualifications

• SME status in veterinary pharmaceutical promotion.
• Prior experience with Health and Wellness products or NASC.
• Experience with Advertising and Promotional materials for eCommerce platforms.
• Experience in Labeling.