Midrand: Regulatory Affairs Manager posted by Hire Resolve

About the Role

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.

Key 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 SOPs in line with Global SOPs.
• Manage internal and external audits (e.g., Global & SAHPRA)
• Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation.
• Manage product complaints and deviations.
• Maintain regulatory documentation filing system.
• Ensure regulatory compliance and quality-related records are available and retained.
• Coordinate product recall or market withdrawal when necessary.
• Obtain and distribute updated information on domestic and international laws.
• Report ADR to Global Safety and SAHPRA and follow up on Adverse Drug Reactions (ADRs).
• Conduct pharmacovigilance training for local staff
• Answer requests from the Regulatory Authority in cooperation with Global Safety

Requirements

• B. Pharm (Bachelor of Pharmacy)
• Registration with the South African Pharmacy Council (SAPC)
• Minimum 10 years experience in Regulatory Affairs with human medicine and biologicals experience.
• Product registration and dossier maintenance.
• Pharmacovigilance experience and knowledge of SAHPRA submission portals.
• Launch procedures for new products.
• QA processes, APQRs, customer complaints.

Qualifications

• Registration with the South African Pharmacy Council (SAPC)

Salary & Benefits

Salary: negotiable.