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 & Experience:
Minimum of a bachelor’s degree in a relevant scientific or veterinary discipline, 
At least 3-5 years’ experience in international pharmaceutical industry, including experience in regulatory. 
Ideally experience with veterinary vaccines and/or products derived using rDNA technology. 
Proficient in scientific written and spoken English. Additional language skills are a plus.

Personal attributes:
Self-starter takes initiative.
Team player essential,
Ability to handle several projects simultaneously.
Good organizational, prioritization and time management skills. Can work effectively under pressure.
Excellent attention to detail.
Proactive: identify regulatory risks and propose solutions.
Demonstrate integrity.