Regulatory Affairs Manager

Full-time Compliance & Regulatory Affairs

Hire Resolve's client is actively seeking a Regulatory Affairs Manager to join their team in Midrand, Gauteng. As a Regulatory Affairs Manager, you will be responsible for ensuring a thorough and seamless product registration process and dossier maintenance. You will ensure that the company complies with all regulations and maintains pharmacovigilance requirements.

Responsibilities

• Lead, manage, and execute strategic direction as the regulatory affairs manager.
• Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications.
• Provide input to the regulatory strategy in line with business objectives.
• Manage and implement safety updates where required.
• Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations.
• Handle license renewals with service providers such as SAHPRA and the South African Pharmacy Council (SAPC)
• Write and develop S...