Position Details Key requirements: ? Understanding of the international and European Veterinary Medicines regulatory framework and guidelines.
? Understanding of the Regulatory Submission procedures in EU and the international area.
? Understanding of the Labelling and artwork management ? Technical knowledge about Veterinary Medicines quality/safety/efficacy requirements.
Responsibilities: ? Provide regulatory support for the company's veterinary vaccine portfolio.
? Support all regulatory aspects of assigned projects in accordance with the business strategy, priorities and timelines.
? Establish and maintain effective working relationships with other PAHC business units (Manufacturing, Quality and Marketing) to ensure regulatory perspectives are incorporated into business plans.
? Supports all types of product lifecycle activities ? Supports writing responses to questions raised by regulatory authorities.
? Prepare and organize the regulatory package submission to the different countries (international area) ? Cross functions support: o Supports quality in implementing Regulatory authorities approvals, o Supports Supply chain with regulatory information on the products o Supports CCP process by assessing impact of the changes on existing registrations and implement the variation process o Ensures the Artwork management process is under control, approved artworks are communicated to the right stakeholders on time, Education