Zoetis is the leading animal health company, dedicated to supporting its customers and their businesses. Building on more than 60 years of experience in animal health, Zoetis discovers, develops, manufactures and markets veterinary vaccines and medicines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Zoetis serves veterinarians, livestock producers and people who raise and care for farm and companion animals with sales of its products in more than 100 countries. For more information, visit www.zoetis.com
For our Sub-Saharan Africa team, located in Zaventem, Belgium and Johannesburg, South Africa, we are looking for a Regulatory Affairs Senior Associate to manage our product portfolio in Central and East Africa, in particular Kenya and Tanzania.
- To provide Regulatory Affairs support to the local affiliate in order to help the markets achieve their revenue and growth targets.
- Obtain new product registrations and special import permits (including dossier compilation and submission) in line with local and regional strategies and renew or extend them as necessary.
- Maintain product registration files, including compilation and submission of variation applications as necessary, with respect to changes in manufacturing, product testing and specifications, safety and efficacy information, and/or changes in local regulations.
- Ensure manufacturing site GMP status meets the requirements of each market and organise inspections as necessary.
- Preparation and/or approval of product labels and package inserts (Artwork) in accordance with the registration file.
- Review and approval of advertising and promotional materials, as it concerns compliance with the product registrations and local regulations.
- Ensure that local pharmacovigilance procedures are in compliance with corporate standards and local requirements.
- Represent Zoetis to the Competent Authorities for all product registration activities.
- Oversight of the budget for, and spending on, Regulatory Affairs within the local affiliate.
- Compliance with Zoetis regulatory and quality procedures, including use of internal databases, tracking systems and records management.
- You are a Pharmacist with at least 5 years’ experience of Regulatory Affairs for pharmaceutical or vaccine products in Central or East Africa, preferably in Kenya or Tanzania.
- Knowledge of mutual recognition procedures and/or Good Manufacturing and Distribution Practice (GMP/GDP) would be an advantage.
- You are self-motivated with excellent organizational skills and attention to detail, and competent in the use of MS Office applications.
- Fluency in English is essential, and French would also be an asset.
- A challenging function in a multinational, innovative working environment with room for ownership & personal development.
- A competitive compensation & benefits package.