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.
• Oversee the implementation and maintenance of QMS to ensure compliance with industry standards and regulations.
• Identify areas for improvement within the quality system and implement corrective and preventive actions.
• Provide training to staff on quality standards, regulatory requirements, and best practices.

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.
• Knowledge of Regulations, Acts, and Guidelines for South Africa and East Africa.
• Microsoft Office Suite proficiency.
• Familiarity with ZAZIBONA processes and eCTD submissions.
• Systems knowledge.
• Microsoft office suite including Word, Excel, Power Point at an Intermediate level.

Qualifications

No specific qualifications mentioned in the original job description.

Salary & Benefits

Salary: negotiable.