About this role
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Your Role: Regulatory Affairs Manager SASSA
As Regulatory Affairs Manager SASSA, you will support the maintenance of existing and registration of new animal health products, including therapeutics, feed additives, biocides and care products. Based in Centurion, Gauteng, South Africa, you will provide regulatory, scientific, technical and strategic support, with a strong focus on South African Health Products Regulatory Authority portfolio management and export market growth.
Your Responsibilities:
- Manage regulatory compliance and lifecycle activities for the existing and future portfolio, including submissions, variations, renewals and referrals to the South African Health Products Regulatory Authority and other relevant authorities.
- Develop and implement regulatory strategies for export markets across the region, while building effective relationships with competent authorities and external regulatory partners.
- Coordinate packaging development and artwork activities, including the release of production artwork through the Elanco Artwork System.
- Review and approve promotional materials in PromoMats, and coordinate national regulatory issues, submissions and packaging updates.
- Maintain regulatory information in systems such as Veeva Vault RIM, collaborate with internal and external stakeholders, and lead regional Regulatory Affairs projects as required.
What You Need to Succeed (minimum qualifications):
- Pharmacist qualification.
- Practical understanding of regulatory compliance activities, including submissions, variations, renewals and marketing authorisation lifecycle management.
- Good computer skills, including Microsoft Word, Microsoft Excel and data management.
- Excellent interpersonal and communication skills for effective collaboration across countries, functions and external stakeholders.
- Strong attention to detail, planning and organisational skills, with the ability to set priorities and assess risk.
What will give you a competitive edge (preferred qualifications):
- Similar experience from the animal health industry.
- Fluent English.
Additional Information:
- Travel: Less than 10%.
- Location: Centurion, Gauteng, South Africa.
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
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Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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