Regulatory Affairs Manager SASSA

About the role

Elanco, a global leader in animal health, is looking for a Regulatory Affairs Manager SASSA based in Centurion, Gauteng, South Africa. The role supports the maintenance of existing and registration of new animal health products, including therapeutics, feed additives, biocides and care products, with a strong focus on the South African Health Products Regulatory Authority portfolio and export market growth.

Key responsibilities

• Manage regulatory compliance and lifecycle activities for the current and future portfolio, including submissions, variations, renewals and referrals to the South African Health Products Regulatory Authority and other authorities.
• Develop and implement regulatory strategies for export markets across the region and build relationships with competent authorities and external regulatory partners.
• Coordinate packaging development and artwork, including releasing 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.

Required profile

• Pharmacist qualification.
• Practical understanding of regulatory compliance, including submissions, variations, renewals and marketing authorisation lifecycle management.
• Preferred: similar experience in the animal health industry and fluent English.

Required skills

• Good computer skills, including Microsoft Word, Microsoft Excel and data management.
• Excellent interpersonal and communication skills for cross-country, cross-functional collaboration.
• Strong attention to detail, planning and organisational skills, with the ability to set priorities and assess risk.