Regulatory and Quality Specialist

Top Vitae Recruitment; Midrand; On-site; ZAR 520,000 - 780,000; Full time

Job summary

Top Vitae Recruitment seeks a Regulatory Affairs and QC specialist to oversee product registrations, quality control and technical documentation across markets. The role requires coordinating submissions, maintaining records and providing regulatory guidance during development.

You will ensure compliance with regulatory requirements, manage documentation, and support product development with cross-functional teams, including multiple African markets.

Qualifications

• A relevant tertiary qualification in Chemistry, Microbiology, Biochemistry, Biotechnology, Food Science, Chemical Engineering, or a related scientific discipline.
• A qualification or formal training in Regulatory Affairs, Quality Management, or a related field would be advantageous.
• Additional training in laboratory quality systems, analytical testing, ISO standards, or quality-management systems would be advantageous.
• Relevant experience in regulatory affairs, including product registrations, renewals and ongoing compliance with regulatory requirements.
• Experience managing product registrations and regulatory documentation across multiple countries; experience in African markets would be a strong advantage.
• Practical experience in Quality Control, laboratory testing, product specifications, investigation of non-conforming products and corrective actions.
• Experience preparing and maintaining technical documentation, registration dossiers, laboratory records and product specifications.
• Experience coordinating laboratory activities or supervising laboratory/QC personnel would be advantageous.
• Strong analytical, problem-solving, documentation and cross-functional communication skills, with the ability to manage competing regulatory, QC and product-development priorities.

Responsibilities

• Ensure that every of the company's product is appropriately registered, authorised, notified, licensed or otherwise approved by the relevant authority in each country where the company operates, as required before the product is marketed or sold.
• Identify applicable legislation, regulatory authorities, product classifications, registration pathways, documentation requirements, submission timelines, labelling requirements, restrictions and validity periods.
• Prepare and manage product registration applications and supporting dossiers; liaise with relevant authorities, respond to queries and track applications through to approval.
• Maintain an accurate central register of product registrations by country, including registration numbers, approval status, expiry dates, renewal dates and relevant correspondence.
• Plan and manage renewals, amendments, variations, dossier updates and other regulatory submissions to prevent lapses in registration or non-compliance.
• Provide regulatory guidance during product development to ensure that proposed formulations, product claims, technical data and documentation meet the requirements of the intended markets.
• Maintain current and accessible regulatory records, certificates, licences, approvals and related product documentation.

Skills

Analytical skills

Problem-solving

Cross-functional communication

Documentation

Regulatory coordination

Education

Tertiary qualification in Chemistry, Microbiology, Biochemistry, Biotechnology, Food Science, Chemical Engineering or related field

Regulatory Affairs / Quality Management training

ISO standards / quality-management systems training

Job description

Key Accountabilities

Regulatory

• Ensure that every of the company's product is appropriately registered, authorised, notified, licensed or otherwise approved by the relevant authority in each country where the company operates, as required before the product is marketed or sold.

• Identify applicable legislation, regulatory authorities, product classifications, registration pathways, documentation requirements, submission timelines, labelling requirements, restrictions and validity periods.

• Prepare and manage product registration applications and supporting dossiers; liaise with relevant authorities, respond to queries and track applications through to approval.

• Maintain an accurate central register of product registrations by country, including registration numbers, approval status, expiry dates, renewal dates and relevant correspondence.

• Plan and manage renewals, amendments, variations, dossier updates and other regulatory submissions to prevent lapses in registration or non-compliance.

• Provide regulatory guidance during product development to ensure that proposed formulations, product claims, technical data and documentation meet the requirements of the intended markets.

• Maintain current and accessible regulatory records, certificates, licences, approvals and related product documentation.

Quality Control (QC)

• Take accountability for the effective operation and ongoing improvement of the company's Quality Control and Customer Services laboratory activities.

• Develop, implement and maintain QC procedures, sampling plans, testing programmes, specifications, analytical methods and test protocols to ensure reliable, accurate and traceable results.

• Review QC results and authorise the release or rejection of finished products against approved specifications, ensuring that non-conforming products are not released.

• Ensure that laboratory equipment is suitably maintained and calibrated, and that testing methods are appropriate and consistently applied.

• Monitor product quality and consistency, investigate out-of-specification results, non-conforming products and recurring quality issues, and implement corrective and preventive actions.

• Investigate product quality complaints, establish root causes where possible and coordinate appropriate corrective actions with relevant departments.

• Ensure Certificates of Analysis and other QC records are accurate, complete and issued appropriately.

• Oversee laboratory priorities, workload, procedures, safety and training, and support the development of laboratory capability.

• Maintain accurate and controlled QC documentation, including product specifications, test methods, laboratory records and investigation reports.

Product Documentation and Technical Support

• Maintain accurate, current and controlled technical and regulatory product documentation, including Technical Data Sheets, Safety Data Sheets, product specifications, labels requiring technical or regulatory approval, test methods, formulation records and technical reports.

• Support customer trials, technical investigations, troubleshooting and product-quality enquiries where specialist formulation or QC input is required.

Qualification Requirements

• A relevant tertiary qualification in Chemistry, Microbiology, Biochemistry, Biotechnology, Food Science, Chemical Engineering, or a related scientific discipline.

• A qualification or formal training in Regulatory Affairs, Quality Management, or a related field would be advantageous.

• Additional training in laboratory quality systems, analytical testing, ISO standards, or quality-management systems would be advantageous.

• Relevant experience in regulatory affairs, including product registrations, renewals and ongoing compliance with regulatory requirements.

• Experience managing product registrations and regulatory documentation across multiple countries; experience in African markets would be a strong advantage.

• Practical experience in Quality Control, laboratory testing, product specifications, investigation of non-conforming products and corrective actions.

• Experience preparing and maintaining technical documentation, registration dossiers, laboratory records and product specifications.

• Experience coordinating laboratory activities or supervising laboratory/QC personnel would be advantageous.

• Strong analytical, problem-solving, documentation and cross-functional communication skills, with the ability to manage competing regulatory, QC and product-development priorities.