MidFull TimeEN
Experiencing together a unique human adventure
Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
The Regulatory Affairs Specialist will be responsible for managing all regulatory submissions, approvals, and compliance activities for veterinary medicines and related animal health products in South Africa and Africa. This role requires in-depth knowledge of local regulatory requirements, excellent project management skills, and the ability to liaise effectively with relevant regulatory bodies.Key Responsibilities:
Registration Management: Prepare, compile, review, and submit all dossiers and documentation required for new product registrations, variations, renewals, and transfers in accordance with South African and African regulatory requirements, including those governed by the South African Health Products Regulatory Authority (SAHPRA) (Act 101 of 1965), National Department of Agriculture (NDA) (Act 36 of 1947), and relevant African Markets.
Compliance & Maintenance: Maintain the registration status and product life cycle of all existing products by managing post-approval commitments, ensuring timely submissions of variations, and tracking renewal timelines.
Regulatory Intelligence: Monitor, interpret, and communicate changes in the South African and African Markets regulatory landscape, guidelines, and legislation (e.g., pharmacovigilance, advertising, and labeling) and assess their impact on company products and strategies.
Documentation: Ensure all product information (labels, package inserts, and promotional materials) complies with approved registrations and local legislation.
Cross-Functional Liaison: Collaborate closely with Quality Assurance, Research & Development, Marketing, and Supply Chain teams to ensure all activities meet regulatory standards from development through to distribution.
Authority Interaction: Serve as the primary point of contact for regulatory authorities, responding to queries, providing clarification on submissions, and supporting regulatory inspections.
Archiving: Maintain comprehensive and organized electronic and hard-copy regulatory archives and databases.
Qualifications and Experience:
Bachelor’s degree in Pharmacy, Veterinary Science, Life Sciences, or a related field. A Master's degree in Regulatory Affairs is advantageous.
Minimum of 3-5 years of experience in Regulatory Affairs within the South African pharmaceutical, animal health, or veterinary industry.
Proven experience in compiling and submitting dossiers to the South African regulatory authority.
Solid understanding of the requirements for product registration (e.g., efficacy, safety, and quality data).
Skills and Competencies:
Exceptional attention to detail and high degree of accuracy in documentation.
Strong verbal and written communication skills in English, with the ability to articulate complex regulatory requirements clearly.
Excellent organizational and project management skills, with the ability to prioritize and manage multiple submissions simultaneously.
Proficiency in Google Suite / Microsoft Office Suite and experience with regulatory information management systems (RIMS) is preferred.
Proactive, self-motivated, and capable of working independently and as part of a team.
